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: J&J Esketamine, Sanofi Caplacizumab Lead Off September Submissions; US FDA Says No To Nucala

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Complete Response Letters Regulation

Keeping Track: An Approval For Ajovy, A CRL For Ruconest, And Some Submissions from J&J

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

Keeping Track: AstraZeneca Wins Approval For Lumoxiti, AbbVie Expands Label For Venclexta With MRD Data, and FDA Delays Acorda's Inbrijia NDA

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

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
See All
UsernamePublicRestriction

Register