FDA

In its continuous endeavor to bolster the competitiveness of the generics market, the US Food and Drug Administration (FDA) updated its list of ‘off-patent, off-exclusivity drugs without an approved generic’. This update is part of FDA’s initiative to improve transparency and encourage the…
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The US Food and Drug Administration (FDA) has released draft guidance for public consultation on the use of the Inactive Ingredient Database (IID). The document is intended to provide information on how to use the IID when choosing inactive ingredients. The guidance describes the Food and Drug…
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A BioPharma Dive article The Food and Drug Administration's top drug regulator sharply criticized the current clinical trial regime, calling for industry to embrace more collaborative studies. "I believe the clinical trial system is broken," said Janet Woodcock, who has worked at the agency…
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12. August 2018 The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. In concertwiththe method revamp, the agency introduced a multiyear…
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29. January 2018 (Reuters) - The head of the U.S. Food and Drug Administration on Thursday said it is preparing a new, more restrictive policy targeting what drugs compounding pharmacies can produce that do not go through the agency's approval process. FDA…
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30. October 2017 Training Date: April 26th & 27th, 2018 Location: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA Length: 2 Days Price: Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00…
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