Pfizer, Gilead and others seek clarifications on trial designs outlined in FDA's UC and Crohn's draft guidance
Pharmas act to make sure their voices get heard — and before the FDA it’s no different. Especially when it relates to draft guidance.
Multiple Big Pharma companies sought tweaks from the FDA on draft guidance related to the development of new drugs for ulcerative colitis and Crohn’s disease. Those two indications are key therapeutic areas for several of the major pharma players.
The drafts explain the FDA’s current thinking around how to design clinical trials for these two disease areas, including recommendations for trial population, trial design, and efficacy and safety considerations.
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