Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Performance Tracker

Set Alert for FDA Performance Tracker

Keeping Track: A Second Straight Burst Of FDA Approvals

The latest drug approval and development news from our US FDA 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

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

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
See All
UsernamePublicRestriction

Register