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 5, 2009
By:Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology
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.
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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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November 5, 2009
By:Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology
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.
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November 5, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
Company and People Notes: sanofi aventis forms pact with Micromet; Laureate Pharma adds members to its business team.
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November 5, 2009
By:Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
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
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November 2, 2009
By:Susan J. Schniepp
Pharmaceutical Technology
With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.
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November 2, 2009
By:Michelle Hoffman
Pharmaceutical Technology
While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too.
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November 2, 2009
By:Jill Wechsler
Pharmaceutical Technology
The heightened focus on risk raises concerns about delays in approving new drugs.
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