FDA Performance Tracker
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US FDA received several applications for new molecular entities last week, including a BLA for Alphaeon's Botulinum toxin that came just three years after number trails began.
Recommendations on drugs awaiting approval from the European Medicines Agency's Committee for Medicinal Products for Human Use, and updates on the marketing authorization applications for individual products. Updated monthly.
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.
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