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FDA Performance Tracker

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Keeping Track: Amarin And Nektar Signal Delays, DBV Returns, And Provention Notches A BTD

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

Drug Review Complete Response Letters Regulation

Keeping Track: US FDA Approvals For Ibsrela, Gvoke And Nucala; A BTD For Tepotinib

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

Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD

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

US FDA 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.

US FDA 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.

US FDA Performance Tracker Approvals

Pending Biosimilars

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

US FDA Performance Tracker Biosimilars

Advisory Committees

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

US FDA Performance Tracker Advisory Committees

Complete Response Letters

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

US FDA Performance Tracker Complete Response Letters

QIDP Designations

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

US FDA Performance Tracker Review Pathway

User Fee Goal Dates

Estimated FDA review deadlines for pending applications. Updated weekly.

US FDA Performance Tracker Approvals
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