FDA Performance Tracker
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The latest drug development news and highlights from our FDA Performance Tracker.
Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.
Drug review recommendations from FDA advisory panels, including regulatory actions. Updated weekly.
Details of action letters issued by US FDA, regularly updated with new announcements.
New molecular entities and therapeutic biologics cleared by the US FDA's Center for Drug Evaluation and Research. Updated regularly with new approvals.
Qualified Infectious Disease Product Designations granted by FDA. Updated upon new designations.
Estimated FDA review deadlines for pending applications. Updated weekly.
Listing of all ‘breakthrough’ drugs, including status and basis of designation. Updated weekly.
Biologics cleared by the Center for Biologics Evaluation and Research, including vaccines, cellular products, antitoxins and immunoglobulins. Updated regularly with new approvals.
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