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FDA

FDA publishes guidance for Inactive Ingredient Database

The US Food and Drug Administration (FDA) has released draft guidance for public consultation on the use of the Inactive Ingredient Database (IID).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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FDA’s Woodcock: ‘The clinical trial system is broken

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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