Regulation: Standards, policy, compliance, and enforcement for good manufacturing practices and good laboratory practices - Pharmaceutical Technology

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Regulation
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.
  • FDA Dedicates Building One at White Oak Research Center


    ePT--the Electronic Newsletter of Pharmaceutical Technology

    The US Food and Drug Administration dedicated historic Building One at the White Oak Federal Research Center in Silver Spring, Maryland.

    Prescription Information Needs to be More Useful


    ePT--the Electronic Newsletter of Pharmaceutical Technology

    A newly released study from the US Food and Drug Administration demonstrates that the printed information retail pharmacies provide to patients regarding medication use and risk of their prescriptions is not easy to read or understand.

    FDA Issues Draft Guidance of Genotoxic Impurities


    ePT--the Electronic Newsletter of Pharmaceutical Technology

    The US Food and Drug Administration issued a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.

    Company and People Notes: Abbott to Acquire Ibis Biosciences; Pfizer Appoints Senior VP of Litigation; More...


    ePT--the Electronic Newsletter of Pharmaceutical Technology

    Also, Crucell and DSM announce deals with GSK, Talecris, and CSL; Nobel Prize winner Luc Montagnier joins Viral Genetics; more...

    EMC Documentum DCM Manages Controlled Content


    In this white paper, you'll read a detailed description of EMC Documentum Compliance Manager (DCM), its features, capabilities, and customer benefits. See how DCM can help you manage the lifecycle of controlled or regulated content to achieve compliance with external regulations and internal policies.

    FDA Releases Draft Guidance for OTC Labeling


    ePT--the Electronic Newsletter of Pharmaceutical Technology

    The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

    PhRMA Revises Principles for DTC Ads


    ePT--the Electronic Newsletter of Pharmaceutical Technology

    The Pharmaceutical Research and Manufacturers of America (PhRMA) adopted measures to strengthen its Guiding Principles for Direct to Consumer (DTC) Advertisements about Prescription Medicines.

    Company and People Notes: Hovione to Acquire Pfizer API site; Xceleron Appoints Michael Butler President and CEO; More...


    ePT--the Electronic Newsletter of Pharmaceutical Technology

    Also, BASF opens lab in Mumbai; Evotek president and CEO to resign; more...

    Guidance for Orally Disintegrating Tablets Issued


    ePT--the Electronic Newsletter of Pharmaceutical Technology

    A US Food and Drug Administration guidance issued Tuesday provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs).

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