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.
November 19, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more...
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November 19, 2009
By:Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
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).
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November 19, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA has approved a fifth influenza A (H1N1) vaccine, manufactured by ID Biomedical.
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November 19, 2009
By:Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology
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.
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November 12, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Commissioner Hamburg addresses the nation's doctors in a letter about the influzenza A (H1N1) virus and vaccine.
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November 12, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
Company and People Notes: 3M forms agreement with VaxInnate; TRIN Pharma appoints CEO; More...
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November 12, 2009
By:Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology
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.
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November 12, 2009
By:Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
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.
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November 5, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system.
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