http://pharmtech.findpharma.com/pharmtech/Regulation/Article/list/40946 Industry guidances and drafts by organizations like FDA, ICH, EMEA, USP & IPEC. Harmonization. Government policy. Validation, inspection, CGMP, imports & safety. Quality by Design (QbD), process analytical technology. 2009-11-21T20:41:30Z http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Nov-16-2009-GSK-and-Nabi-Form-Nicotine-Vac/ArticleStandard/Article/detail/642581?contextCategoryId=40946&ref=25 Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more... 2009-11-19T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472009/642581null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/GSK-Donates-Influenza-A-H1N1-Vaccine-to-WHO/ArticleStandard/Article/detail/642555?contextCategoryId=40946&ref=25 Last week, GlaxoSmithKline (GSK, London) agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO). 2009-11-19T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472009/642555null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Regulatory-Roundup-FDA-Expands-Use-of-CSLs-H1N1-Va/ArticleStandard/Article/detail/642580?contextCategoryId=40946&ref=25 FDA has approved a fifth influenza A (H1N1) vaccine, manufactured by ID Biomedical. 2009-11-19T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472009/642580null HTML http://pharmtech.findpharma.com/pharmtech/News/Rx-360-Takes-on-Europe-Talks-to-PharmTech-About-Sh/ArticleStandard/Article/detail/642579?contextCategoryId=40946&ref=25 The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance. 2009-11-19T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/472009/642579null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Regulatory-Roundup-FDA-Introduces-Safe-Use-Initiat/ArticleStandard/Article/detail/640917?contextCategoryId=40946&ref=25 Also, Commissioner Hamburg addresses the nation's doctors in a letter about the influzenza A (H1N1) virus and vaccine. 2009-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462009/640917null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Week-of-Nov-9-2009-Merck-and-Schering-Plough-Begin/ArticleStandard/Article/detail/640959?contextCategoryId=40946&ref=25 Company and People Notes: 3M forms agreement with VaxInnate; TRIN Pharma appoints CEO; More... 2009-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462009/640959null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/EU-Issues-Strategy-for-Influenza-A-H1N1-Vaccine-Be/ArticleStandard/Article/detail/640749?contextCategoryId=40946&ref=25 The European Medicines Agency, the European Center for Disease Prevention and Control, and the Heads of Medicines Agencies issued a European strategy for H1N1 vaccine benefit–risk monitoring. 2009-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462009/640749null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/PhRMA-Reacts-to-House-Healthcare-Reform-Bill/ArticleStandard/Article/detail/640751?contextCategoryId=40946&ref=25 On Sunday, Nov. 8, 2009, the Pharmaceutical Research and Manufacturers of America (PhRMA) expressed its disappointment with the US House of Representatives's healthcare-reform bill. 2009-11-12T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/462009/640751null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Regulatory-Roundup-FDA-Issues-Guidance-on-In-Vitro/ArticleStandard/Article/detail/639001?contextCategoryId=40946&ref=25 Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639001null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Nov-2-2009-Eli-Lilly-Opens-Biotech-Center-/ArticleStandard/Article/detail/639212?contextCategoryId=40946&ref=25 Company and People Notes: sanofi aventis forms pact with Micromet; Laureate Pharma adds members to its business team. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639212null HTML http://pharmtech.findpharma.com/pharmtech/Formulation/USP-Revises-Excipient-Standards-to-Limit-Contamina/ArticleStandard/Article/detail/639036?contextCategoryId=40946&ref=25 In response to a request from the US Food and Drug Administration, the US Pharmacopeial Convention (USP) revised its standards for propylene glycol and sorbitol solution 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639036null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/SOCMA-Hails-FDA-Action-on-Citizen-Petition-Regardi/ArticleStandard/Article/detail/639211?contextCategoryId=40946&ref=25 The Society of Chemical Manufacturers and Affiliates (SOCMA) reported last week that the US Food and Drug Administration responded to the association's citizen petition relating to the inspection process of foreign drug-manufacturing facilities. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639211null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/ICH-Adopts-Pharmacopeial-Text-Annexes-and-Prepares/ArticleStandard/Article/detail/638997?contextCategoryId=40946&ref=25 Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts. 2009-11-05T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638997null HTML http://pharmtech.findpharma.com/pharmtech/Inside+Standards/Insider-Solutions-A-New-Direction-for-USP/ArticleStandard/Article/detail/639205?contextCategoryId=40946&ref=25 With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639205null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Sharing-Supply-Chain-Security/ArticleStandard/Article/detail/639209?contextCategoryId=40946&ref=25 A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639209/pt1109_coverstory_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639209/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639209null XML http://pharmtech.findpharma.com/pharmtech/IT/Stay-Afloat-with-Lessons-Learned/ArticleStandard/Article/detail/639195?contextCategoryId=40946&ref=25 FDA's Edwin Rivera-Martinez on dodging supply-chain challenges. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639195null XML http://pharmtech.findpharma.com/pharmtech/IT/DIY-Healthcare-Reform/ArticleStandard/Article/detail/639194?contextCategoryId=40946&ref=25 While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639194null XML http://pharmtech.findpharma.com/pharmtech/Article/Are-We-Abandoning-IQ-and-OQ/ArticleStandard/Article/detail/639193?contextCategoryId=40946&ref=25 New standards may overlook critical qualification needs. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639193null XML http://pharmtech.findpharma.com/pharmtech/Article/Position-Paper-Are-We-Abandoning-IQ-and-OQ/ArticleStandard/Article/detail/639199?contextCategoryId=40946&ref=25 The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment." 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639199/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639199null XML http://pharmtech.findpharma.com/pharmtech/Article/Safety-versus-Speed-in-Drug-Development/ArticleStandard/Article/detail/639197?contextCategoryId=40946&ref=25 The heightened focus on risk raises concerns about delays in approving new drugs. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639197null XML http://pharmtech.findpharma.com/pharmtech/Article/Changes-for-Better-or-Worse/ArticleStandard/Article/detail/639201?contextCategoryId=40946&ref=25 New tests solve one issue, but cheaper plastic and new stoppers cause problems. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639201null XML http://pharmtech.findpharma.com/pharmtech/Ingredients/Regulatory-Update-The-IPEC-Novel-Excipient-Safety-/ArticleStandard/Article/detail/639204?contextCategoryId=40946&ref=25 The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients. 2009-11-02T05:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/639204null XML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Risk-Management-for-Aseptic-Processing/ArticleStandard/Article/detail/638758?contextCategoryId=40946&ref=25 The author discusses the risks involved with aseptic processing, methods and tools used to identify and control risk, and regulatory guidelines relevant to the risk-management process. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638758/pt1109-sup-needles-CV-B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638758null XML http://pharmtech.findpharma.com/pharmtech/Regulation/USPs-Ferrules-and-Caps-Labeling-Changes-Put-on-Hol/ArticleStandard/Article/detail/638764?contextCategoryId=40946&ref=25 This article provides an update to the author's Viewpoint column, "Changes to Vial Labels May Affect Patient Safety," which ran in Pharmaceutical Technology's March 2009 issue. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638764/pt1109-sup-needles-CV-B_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/452009/638764null XML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Regulatory-challenges-of-inhaler-testing/ArticleStandard/Article/detail/636406?contextCategoryId=40946&ref=25 Mark Copley discusses the methods used for DPI testing and the challenges presented by the current regulatory framework. 2009-11-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/636406/Inhaler_web_thumbnail.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/636406null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-26-2009-OXiGENE-to-Acquire-VaxGen-Warn/ArticleStandard/Article/detail/637174?contextCategoryId=40946&ref=25 Also, Astellas and Medivation sign development pact; WuXi PharmaTech appoints VP of business development, more... 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637174null HTML http://pharmtech.findpharma.com/pharmtech/News/GAO-Report-Calls-Out-FDAs-Poor-Oversight-of-Accele/ArticleStandard/Article/detail/637175?contextCategoryId=40946&ref=25 The US Food and Drug Administration needs to enhance its oversight of drugs approved on the basis of surrogate endpoints, according to a September report from the Government Accountability Office (GAO) that was released this week. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637175null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Regulatory-Roundup-FDA-Authorizes-Emergency-Use-of/ArticleStandard/Article/detail/637172?contextCategoryId=40946&ref=25 Also, FDA's DDMAC issues Warning Letter to King Pharmaceuticals; draft guidance released for SPL standards for content of labeling. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637172null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/House-Committee-Passes-IST-Requirements-in-Chemica/ArticleStandard/Article/detail/637178?contextCategoryId=40946&ref=25 The House Energy and Commerce Committee approved H.R. 2868, the "Chemical Facility Anti-Terrorism Act of 2009," a measure to modify and codify existing requirements of the Chemical Facility Anti-Terrorism Standards (CFATS) program. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637178null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Tracks-Influenza-A-Treatment-with-Prescription/ArticleStandard/Article/detail/637177?contextCategoryId=40946&ref=25 The US Food and Drug Administration is using prescription data from Wolters Kluwer Pharma Solutions to track the treatment of influenza A (H1N1) and other influenza viruses, according to a statement that the company released last week. 2009-10-29T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/442009/637177null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Issues-New-Guidance-on-Drug-Labeling-and-Pharm/ArticleStandard/Article/detail/635534?contextCategoryId=40946&ref=25 The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information. 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635534null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-19-2009-Lonza-Drops-Bid-for-Patheon-Pe/ArticleStandard/Article/detail/635533?contextCategoryId=40946&ref=25 Company and People Notes: SurModics forms agreement with Roche and Genentech; Hospira names Daphne Jones senior VP and chief information officer; more... 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635533null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Regulatory-Roundup-FDA-and-FTC-Issue-Joint-Warning/ArticleStandard/Article/detail/635530?contextCategoryId=40946&ref=25 The two agencies issued a joint Warning Letter to the owners of a website selling unapproved products intended to treat the swine flu virus. 2009-10-22T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/432009/635530null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Regulatory-Roundup-HHS-Approves-100th-PEPFAR-Drug/ArticleStandard/Article/detail/633984?contextCategoryId=40946&ref=25 Also, USAID and USP launch counterfeiting public service campaign in Cambodia. 2009-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422009/633984null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-12-2009-GSK-and-Prosensa-Form-Pact-Car/ArticleStandard/Article/detail/633981?contextCategoryId=40946&ref=25 Company and People Notes: Bayer Schering Pharma forms collaboration with Compugen; Takeda San Francisco appoints VP of process science; more... 2009-10-15T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/422009/633981null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Releases-Draft-Guidance-for-REMS/ArticleStandard/Article/detail/632127?contextCategoryId=40946&ref=25 The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009. 2009-10-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632127null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Regulatory-Roundup-FDA-Issues-Strategic-Plan-for-R/ArticleStandard/Article/detail/632119?contextCategoryId=40946&ref=25 Also, FDA partners with USDA on produce safety, and the Transparency Task Force announces its second public meeting... 2009-10-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632119null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Oct-5-2009-Merck-and-CSL-Sign-Flu-Vaccine-/ArticleStandard/Article/detail/632124?contextCategoryId=40946&ref=25 Company and People Notes: GSK forms joint venture with China-based Jiangsu Walvax Biotech; Sigma-Aldrich appoints VP and board member; more... 2009-10-08T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632124null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/The-Regulatory-Paradox-of-Laboratory-Developed-Tes/ArticleStandard/Article/detail/631381?contextCategoryId=40946&ref=25 The development of increasingly more complex and sophisticated in vitro diagnostic (IVD) devices by clinical laboratories has precipitated FDA concern regarding a lack of product controls. These tests are often produced using available marketed kits, may include components purchased from a commercial supplier, and are offered for use as a diagnostic service. FDA contends that test ingredients or components used in the production of LDTs are essentially unregulated, therefore, of unpredictable quality. The regulatory boundary between FDA-regulated medical devices LDTs exempt from FDA jurisdiction remains somewhat blurred; however, the looming finalization of the CPG and IDVMIA guidance documents stand to better clarify this borderline. 2009-10-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631381null REMOTE http://pharmtech.findpharma.com/pharmtech/Manufacturing/Pediatric-Exclusivity-and-Drug-Development-Require/ArticleStandard/Article/detail/631379?contextCategoryId=40946&ref=25 Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only a small fraction of the drugs marketed and used as therapies in the United States have been studied in pediatric patients 0–16 years of age. Recent data demonstrates that only about 25% of approved drugs marketed in the United States have adequate pediatric data to support approval of product labeling by FDA for dosing, safety, or efficacy in children. This lack of appropriate pediatric testing and labeling increases the chances of incorrect dosing, thereby exposing pediatric patients to either an increased risk of adverse reactions or less than optimal therapeutic benefits. 2009-10-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631379null REMOTE http://pharmtech.findpharma.com/pharmtech/Whitepapers/Risk-Evaluation-and-Mitigation-Strategies-REMS-Und/ArticleStandard/Article/detail/614075?contextCategoryId=40946&ref=25 On March 25, 2008, new legislation designated as the Food and Drug Administration Amendments Act of 2007 (FDAAA; "the Act") took effect, which directed FDA to develop a systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout its lifecycle, with an explicit focus on postapproval safety. In September 2009, FDA announced a draft guidance to assist sponsors in the preparation of a REMS. The guidance provides links to a number of resources available at FDA to aid in REMS preparation. 2009-10-05T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/312009/614075null REMOTE http://pharmtech.findpharma.com/pharmtech/Article/The-Relevance-of-Continuous-Solid-Oral-Dosage-Proc/ArticleStandard/Article/detail/631713?contextCategoryId=40946&ref=25 The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631713/112_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631713null XML http://pharmtech.findpharma.com/pharmtech/Statistical+Solutions/Square-Root-of-emNem---1-Sampling-Plan/ArticleStandard/Article/detail/631722?contextCategoryId=40946&ref=25 Is the square root of (N) + 1 a statistically valid scheme? 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631722null XML http://pharmtech.findpharma.com/pharmtech/Inside+Standards/Inside-USP-Characterization-of-Heparin-Products/ArticleStandard/Article/detail/632995?contextCategoryId=40946&ref=25 USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632995/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632995null XML http://pharmtech.findpharma.com/pharmtech/Article/Standard-Setting-Bodies-Engage-Russia/ArticleStandard/Article/detail/632991?contextCategoryId=40946&ref=25 As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632991/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632991null XML http://pharmtech.findpharma.com/pharmtech/Article/Sneaky-and-Suspicious/ArticleStandard/Article/detail/631749?contextCategoryId=40946&ref=25 Like life, the workplace also can have many surprises. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631749null XML http://pharmtech.findpharma.com/pharmtech/Article/How-to-Develop-a-Practical-and-Compliant-Vendor-Qu/ArticleStandard/Article/detail/632990?contextCategoryId=40946&ref=25 This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632990/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632990null XML http://pharmtech.findpharma.com/pharmtech/Special+Section%3A+Quality+by+Design/Question-Based-Review-An-FDA-Reviewers-Perspective/ArticleStandard/Article/detail/632992?contextCategoryId=40946&ref=25 The author analyzes, from an agency perspective, whether question-based review has improved product quality or made the review process easier for regulators or for industry. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632992/QBD_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632992/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632992null XML http://pharmtech.findpharma.com/pharmtech/IT/PhRMAs-Stake-in-Reform/ArticleStandard/Article/detail/631752?contextCategoryId=40946&ref=25 The nation's healtcare system needs an overhaul, but it has to be done right. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631752null XML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling/Packaging-Goes-Green/ArticleStandard/Article/detail/632987?contextCategoryId=40946&ref=25 Pharmaceutical companies get ideas for sustainable packaging from other industries. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632987/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632987null XML http://pharmtech.findpharma.com/pharmtech/Article/New-Leadership-Seeks-to-Transform-FDA/ArticleStandard/Article/detail/631717?contextCategoryId=40946&ref=25 Strict enforcement, new rules, and organizational changes signal an activist tone. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631717null XML http://pharmtech.findpharma.com/pharmtech/Article/Progress-Made-on-the-Path-to-Biosimilars/ArticleStandard/Article/detail/631720?contextCategoryId=40946&ref=25 BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631720null XML http://pharmtech.findpharma.com/pharmtech/Special+Section%3A+Quality+by+Design/Building-a-Framework-for-Quality-by-Design/ArticleStandard/Article/detail/632988?contextCategoryId=40946&ref=25 The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632988/QBD_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632988/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632988null XML http://pharmtech.findpharma.com/pharmtech/Article/Quality-by-Design-for-Generic-Drugs/ArticleStandard/Article/detail/631723?contextCategoryId=40946&ref=25 The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631723/QBD_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631723null XML http://pharmtech.findpharma.com/pharmtech/News/EMEA-to-fully-implement-Product-Information-Manage/ArticleStandard/Article/detail/630111?contextCategoryId=40946&ref=25 The EMEA intends to fully implement its Product Information Management (PIM) approach, an initiative designed to improve information management, into the centralized procedure within 2 years, according to a statement of intent from the agency. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/630111null HTML http://pharmtech.findpharma.com/pharmtech/Article/Equivalence-by-Design-for-Advanced-Dosage-Forms-an/ArticleStandard/Article/detail/631716?contextCategoryId=40946&ref=25 FDA has been encouraging drug sponsors to use a systematic approach such as quality-by-design principles for pharmaceutical development. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631716/QBD_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631716null XML http://pharmtech.findpharma.com/pharmtech/Article/Getting-the-Truth-out-of-Dissolution-Testing/ArticleStandard/Article/detail/631721?contextCategoryId=40946&ref=25 Industry, equipment vendors, and regulators are busy refining the precision and reliability of dissolution testing. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631721/Coverstory_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631721null XML http://pharmtech.findpharma.com/pharmtech/Article/Multinational-Firms-Stake-Claims/ArticleStandard/Article/detail/632994?contextCategoryId=40946&ref=25 This article is part of a Special Report on the Emerging Markets of The East, October 2009 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632994/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632994null XML http://pharmtech.findpharma.com/pharmtech/Article/The-Emerging-Markets-of-the-East/ArticleStandard/Article/detail/631710?contextCategoryId=40946&ref=25 The countries of Central and Eastern Europe and the Commonwealth of Independent States are closing in on global pharmaceutical competition. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631710/russia_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631710null XML http://pharmtech.findpharma.com/pharmtech/Special+Section%3A+Quality+by+Design/Academia-Tackles-QbD-Science-NIPTE-Carries-out-FDA/ArticleStandard/Article/detail/632993?contextCategoryId=40946&ref=25 A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632993/QBD_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632993/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632993null XML http://pharmtech.findpharma.com/pharmtech/IT/Looking-Ahead-The-Pharmaceutical-Science-Industry/ArticleStandard/Article/detail/631750?contextCategoryId=40946&ref=25 AAPS President offers hope and solutions for the industry's challenging future. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631750null XML http://pharmtech.findpharma.com/pharmtech/Special+Section%3A+Quality+by+Design/Critical-Challenges-to-Implementing-QbD-A-QampA-wi/ArticleStandard/Article/detail/632986?contextCategoryId=40946&ref=25 Officials from the US Food and Drug Administration discuss best practices for applying quality-by-design concepts. This article contains bonus online-exclusive material. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632986/QBD_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632986/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632986null XML http://pharmtech.findpharma.com/pharmtech/Article/CROs-and-CMOs-Go-Further-East/ArticleStandard/Article/detail/632989?contextCategoryId=40946&ref=25 Contract research organizations such as Covance are heading further east through Europe. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632989/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/632989null XML http://pharmtech.findpharma.com/pharmtech/Article/Global-Regulatory-Submissions-for-QbD-Wyeths-Exper/ArticleStandard/Article/detail/631718?contextCategoryId=40946&ref=25 Representatives of one pilot program participant, Wyeth, outline the experiences and lessons learned for implementing a science- and risk-based approach to drug-development and manufacturing. 2009-10-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631718/QBD_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/412009/631718null XML http://pharmtech.findpharma.com/pharmtech/Manufacturing/FDA-Issues-Proposed-Rule-on-CGMPs-for-Combination-/ArticleStandard/Article/detail/630291?contextCategoryId=40946&ref=25 The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23 Federal Register. 2009-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/630291null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-28-2009-JampJ-and-Crucell-Enter-Colla/ArticleStandard/Article/detail/630279?contextCategoryId=40946&ref=25 Company and People Notes: Boehringer Ingelheim will acquire Wyeth's animal health business; Amsterdam Molecular Therapeutics appoints CEO; more... 2009-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/630279null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/Regulatory-Roundup-FDA-Revises-Announcement-of-Tob/ArticleStandard/Article/detail/630287?contextCategoryId=40946&ref=25 Also, FDA bans candy and fruit-flavored cigarettes, EMEA moves to improve information management. 2009-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/630287null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/EMEA-Recommends-Two-H1N1-Vaccines-for-Authorizatio/ArticleStandard/Article/detail/630295?contextCategoryId=40946&ref=25 On September 25, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline's (GSK) Pandemrix and Novartis's Focetria. 2009-10-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/402009/630295null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Bayer-Receives-Warning-Letter-for-Alleged-Deviatio/ArticleStandard/Article/detail/628581?contextCategoryId=40946&ref=25 The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs). 2009-09-24T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392009/628581null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/FDA-to-Hold-Public-Hearing-on-Online-Drug-Promotio/ArticleStandard/Article/detail/628580?contextCategoryId=40946&ref=25 The US Food and Drug Administration plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices on the Internet and using social media tools, according to a notice in the Sept. 21, 2009, Federal Register. 2009-09-24T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392009/628580null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-21-2009-AstraZeneca-and-Nektar-Sign-L/ArticleStandard/Article/detail/628576?contextCategoryId=40946&ref=25 Company and People Notes: Wyeth and Ambrx form development pact; Elite Pharma appoints CEO and CSO; more... 2009-09-24T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/392009/628576null HTML http://pharmtech.findpharma.com/pharmtech/Regulation/Senate-Finance-Committee-Introduces-Latest-Legisla/ArticleStandard/Article/detail/626927?contextCategoryId=40946&ref=25 The Senate Finance Committee through its chairman, Max Baucus (D-MT), introduced on Sept. 16, 2009, a bill, "America's Healthy Future Act of 2009," representing the latest Congressional proposal for healthcare reform. 2009-09-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382009/626927null HTML http://pharmtech.findpharma.com/pharmtech/News/FDAs-Sharfstein-Outlines-Principles-of-Public-Heal/ArticleStandard/Article/detail/626933?contextCategoryId=40946&ref=25 Speaking to the audience of the 2009 PDA-FDA Joint Regulatory Conference in Washington, DC, this week, US Food and Drug Administration Principal Deputy Commissioner outlined four principles that define FDA's role as a public health agency. 2009-09-17T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/382009/626933null HTML http://pharmtech.findpharma.com/pharmtech/Manufacturing/The-Economical-and-Process-Benefitsnbspof-Steam-Sy/ArticleStandard/Article/detail/625913?contextCategoryId=40946&ref=25 Investing time and money in auditing and optimizing a steam system can pay off quickly, especially because the costs of energy, maintenance, and downtime are steadily rising. 2009-09-16T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/625913null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Most-Firms-Meeting-Postmarketing-Study-Timelin/ArticleStandard/Article/detail/624982?contextCategoryId=40946&ref=25 More than 80% of pharmaceutical and biologics companies are completing their postmarketing studies and regulatory obligations in a timely manner. 2009-09-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/624982null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Sept-7-2009-Facet-Rejects-Biogen-Idecs-Pro/ArticleStandard/Article/detail/624922?contextCategoryId=40946&ref=25 Company and People Notes: Neoprobe and Laureate Pharma form manufacturing agreement; Akela Pharma appoints CEO and chairman; more... 2009-09-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/624922null HTML http://pharmtech.findpharma.com/pharmtech/Drug+Delivery/Controlled-Release-Formulations-a-Popular-Strategy/ArticleStandard/Article/detail/624970?contextCategoryId=40946&ref=25 Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009. 2009-09-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/624970null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Seeks-Data-for-Sentinel-Initiative/ArticleStandard/Article/detail/624929?contextCategoryId=40946&ref=25 The US Food and Drug Administration plans to begin collecting information for its Sentinel Initiative, according to a Sept. 4 Federal Register announcement. 2009-09-10T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/624929null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/REACH-Program-May-Carry-Six-Times-the-Expected-Cos/ArticleStandard/Article/detail/623599?contextCategoryId=40946&ref=25 Implementing Europe's Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) program, will require a massive increase in animal testing and cost six times more than previously estimated. 2009-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623599null HTML http://pharmtech.findpharma.com/pharmtech/News/FDA-Issues-Final-Guidance-on-OTC-Drug-Labeling/ArticleStandard/Article/detail/623595?contextCategoryId=40946&ref=25 The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers. 2009-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623595null HTML http://pharmtech.findpharma.com/pharmtech/Company+and+People+Notes/Week-of-Aug-31-2009-Roche-Purchases-Lonza-Facility/ArticleStandard/Article/detail/623587?contextCategoryId=40946&ref=25 Also, Orexo and Novartis form agreement; Affitech appoints Robert Burns CEO; more... 2009-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623587null HTML http://pharmtech.findpharma.com/pharmtech/Ingredients/USP-to-Develop-Standards-with-Mexican-Commission/ArticleStandard/Article/detail/623593?contextCategoryId=40946&ref=25 The US Pharmacopeial Convention (USP) and the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM) signed a memorandum of understanding (MOU) last week. 2009-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623593null HTML http://pharmtech.findpharma.com/pharmtech/Online+Only/QampA-With-Compliance-Expert-Barbara-Jentges/ArticleStandard/Article/detail/623590?contextCategoryId=40946&ref=25 Later this month, Dr. Barbara Jentges, the managing director at PhACT GmbH, a regulatory consulting and training firm based in Duggingen, Switzerland, will be speaking at the 2nd Vetter Drug Management Leadership Conference in Germany. 2009-09-03T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623590null HTML http://pharmtech.findpharma.com/pharmtech/IT/Quality-by-Enforcement/ArticleStandard/Article/detail/624202?contextCategoryId=40946&ref=25 After years of promomting QbD concepts, FDA's ready to take action on nonconformers. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624202null XML http://pharmtech.findpharma.com/pharmtech/Article/Drug-Master-Files-Requirements-and-Challenges/ArticleStandard/Article/detail/624206?contextCategoryId=40946&ref=25 The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624206/onlineEX_main.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624206null XML http://pharmtech.findpharma.com/pharmtech/Article/Of-Audits-and-Gunk/ArticleStandard/Article/detail/624199?contextCategoryId=40946&ref=25 Thanks to their keen observations, these auditors reveal the true culprits of deviations. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624199null XML http://pharmtech.findpharma.com/pharmtech/IT/Robots-The-Next-Phase-in-Pharmaceutical-Automation/ArticleStandard/Article/detail/624196?contextCategoryId=40946&ref=25 Robotic systems provide flexibility and efficiency (and they're not as difficult to use as you think). This article contains bonus online-exclusive material. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624196/ROBOT_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624196/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624196null XML http://pharmtech.findpharma.com/pharmtech/Inside+Standards/Inside-ICHndashMHLW-Working-Groups-Ramp-up-Quality/ArticleStandard/Article/detail/624195?contextCategoryId=40946&ref=25 Representatives of Japan's MHLW report on recent ICH activities and what the ministry expects from Q11. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624195null XML http://pharmtech.findpharma.com/pharmtech/IT/The-GoNo-Go-Mindset/ArticleStandard/Article/detail/624651?contextCategoryId=40946&ref=25 As new process validation guidelines emerge, industry needs to reinvent how it releases product. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/372009/624651null XML http://pharmtech.findpharma.com/pharmtech/Article/Global-Health-Concerns-Create-Business-Opportuniti/ArticleStandard/Article/detail/624209?contextCategoryId=40946&ref=25 Health crises generate support for new vaccines and treatments for diseases found in developing nations. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624209null XML http://pharmtech.findpharma.com/pharmtech/Packaging+%26+Labeling/Pill-Level-Product-Protection/ArticleStandard/Article/detail/624198?contextCategoryId=40946&ref=25 Authenticating tools help identify counterfeit drug products. This article contains bonus online-exclusive material. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624198/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624198null XML http://pharmtech.findpharma.com/pharmtech/Article/A-Brave-New-Path-for-Pharma/ArticleStandard/Article/detail/624200?contextCategoryId=40946&ref=25 Personalized medicine and integrated healthcare delivery require new business and pricing models. This article contains bonus online-exclusive material. 2009-09-02T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624200/Bonus_main.gif http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/624200null XML http://pharmtech.findpharma.com/pharmtech/Article/Moving-from-Vial-to-Prefilled-Syringe/ArticleStandard/Article/detail/623096?contextCategoryId=40946&ref=25 A Project Manager's Perspective. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623096/Supp12_thumbnail.jpg http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623096null XML http://pharmtech.findpharma.com/pharmtech/Article/Design-and-Construction-of-a-Potent-Pharmaceutical/ArticleStandard/Article/detail/623099?contextCategoryId=40946&ref=25 The author describes the approach taken to develop a facility dedicated to handling potent and cytotoxic drug substances. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623099null XML http://pharmtech.findpharma.com/pharmtech/Article/Market-Outlook-for-Biosimilars/ArticleStandard/Article/detail/623094?contextCategoryId=40946&ref=25 The author reviews the major biopharmaceutical markets' activity and predicts how the markets may evolve. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/623094null XML http://pharmtech.findpharma.com/pharmtech/Whitepapers/The-Executive-Guide-to-Contracts-amp-Chargebacks-M/ArticleStandard/Article/detail/622962?contextCategoryId=40946&ref=25 When it comes to Contracts and Chargebacks - the stakes are high - as credits for chargebacks can often exceed millions of dollars each month. If you find yourself faced with addressing changing regulatory requirements, managing hundreds of contracts, and validating and processing chargeback submissions, we encourage you to learn more in this white paper. 2009-09-01T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/362009/622962null REMOTE http://pharmtech.findpharma.com/pharmtech/Regulation/FDA-Opens-Center-for-Tobacco-Products/ArticleStandard/Article/detail/621585?contextCategoryId=40946&ref=25 On Aug. 19, 2009, the US Food and Drug Administration opened a new Center for Tobacco Products on the agency's White Oak Campus in Silver Spring, Maryland. 2009-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621585null HTML http://pharmtech.findpharma.com/pharmtech/Analytics/Week-of-Aug-24-2009-Warner-Chilcott-Buys-PampG-Pha/ArticleStandard/Article/detail/621551?contextCategoryId=40946&ref=25 Company and People Notes: UCB and Novartis form agreement; AAIPharma appoints VP of regulatory affairs; more... 2009-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621551null HTML http://pharmtech.findpharma.com/pharmtech/News/Electronic-Safety-Reporting-May-Soon-Be-Mandatory-/ArticleStandard/Article/detail/621583?contextCategoryId=40946&ref=25 The US Food and Drug Administration announced in an Aug. 20, 2009 release that it would like to amend postmarket safety reporting regulations "to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format." 2009-08-27T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/352009/621583null HTML http://pharmtech.findpharma.com/pharmtech/News/Academia-Urges-More-Transparency-on-Labels/ArticleStandard/Article/detail/620133?contextCategoryId=40946&ref=25 Researchers from the Stanford University School of Medicine in California are urging the US Food and Drug Administration to demand that drug manufacturers state how new medications compare with similar treatments on product labels. 2009-08-20T04:00:00Z http://pharmtech.findpharma.com/pharmtech/data/articlestandard/pharmtech/342009/620133null HTML