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FDA Performance Tracker

Set Alert for FDA Performance Tracker

Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation United States

European CHMP Opinions And MAA Updates

A monthly-updated listing of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Performance Tracker Approvals

Novel CDER Approvals

New molecular entities and therapeutic biologics cleared by the US FDA's Center for Drug Evaluation and Research. Our FDA Performance Tracker chart is updated regularly with new approvals.

Performance Tracker Approvals

CBER Novel Approvals

Biologics cleared by the Center for Biologics Evaluation and Research, including vaccines, cellular products, antitoxins and immunoglobulins. Updated regularly with new approvals.

Performance Tracker Approvals

Pending Biosimilars

Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.

Performance Tracker Biosimilars

Advisory Committees

Drug review recommendations from FDA advisory panels, including regulatory actions. Updated weekly.

Performance Tracker Advisory Committees

Complete Response Letters

Details of action letters issued by US FDA, regularly updated with new announcements.

Performance Tracker Complete Response Letters

QIDP Designations

Qualified Infectious Disease Product Designations granted by FDA. Updated upon new designations.

Performance Tracker Review Pathway

User Fee Goal Dates

Estimated FDA review deadlines for pending applications. Updated weekly.

Performance Tracker Approvals

Breakthrough Therapy Designations

Listing of all ‘breakthrough’ drugs, including status and basis of designation. Updated weekly.

Performance Tracker Approvals
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