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FDA Performance Tracker

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HIV At US FDA: Gilead's Novel Agent, Viiv's Two-Drug Maintenance Regimen Filed

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

Performance Tracker Approvals

European CHMP Recommendations & MAA Updates

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.

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Pending Biosimilars

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

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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.

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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.

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Breakthrough Therapy Designations

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

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