FDA

Percentage of drug shortage reason, 2013-2017, FDA

Drug shortages mainly due to Quality issues – says Janet Woodcock

30. October 2019

"To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality — Not Just Medicine" By: Janet Woodcock, M.D.,...

USFDA-list-of-drugs-that-need-generic-alternatives, by pharmacompass

List of drugs that need generic alternatives shared by USFDA and China

7. August 2019

In its continuous endeavor to bolster the competitiveness of the generics market, the US Food and Drug Administration (FDA) updated...

FDA-publishes-guidance-for-Inactive-Ingredients-Database

FDA publishes guidance for Inactive Ingredient Database

6. August 2019

The US Food and Drug Administration (FDA) has released draft guidance for public consultation on the use of the Inactive Ingredient Database (IID). The...

FDA’s Woodcock: ‘The clinical trial system is broken

25. November 2018

A BioPharma Dive article The Food and Drug Administration's top drug regulator sharply criticized the current clinical trial regime, calling...

How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

12. August 2018

12. August 2018 The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing...

FDA plans more restrictive policy for bulk drug compounding

29. January 2018

29. January 2018 (Reuters) - The head of the U.S. Food and Drug Administration on Thursday said it is...

Managing Your FDA Inspection: Before, During and After

30. October 2017

30. October 2017 Training Date: April 26th & 27th, 2018 Location: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila...

Drug shortages mainly due to Quality issues – says Janet Woodcock

List of drugs that need generic alternatives shared by USFDA and China

FDA publishes guidance for Inactive Ingredient Database

FDA’s Woodcock: ‘The clinical trial system is broken

How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

FDA plans more restrictive policy for bulk drug compounding

Managing Your FDA Inspection: Before, During and After

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