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FDA Performance Tracker

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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.

Approvals Performance Tracker

Keeping Track: FDA Hands Out Complete Responses, Expedited Pathway Designations

The latest US drug development news and highlights from our Performance Tracker.

Performance Tracker Drug Review

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

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

Novel CDER Approvals

New molecular entities and therapeutic biologics cleared by the US FDA's Center for Drug Evaluation and Research. Updated regularly with new approvals.

Performance Tracker Approvals

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
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