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FDA and Cannabis: Research and Drug Approval Process

The FDA understands that there is increasing interest in the potential utility of cannabis for a variety of medical conditions, as well as research on the potential adverse health effects from use of cannabis. To date, the FDA has not…

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The US Food and Drug Administration (FDA) has released draft guidance for public consultation on the use of the Inactive Ingredient Database (IID).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

FDA Inactive Ingredient Catalogue

The Inactive Ingredient Database provides information on inactive ingredients (excipients) present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. For new drug development…

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…