Pink Sheet is part 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

US FDA Picks Up The Pace Of Complete Response Letters Over June And July

Executive Summary

The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.

You may also be interested in...



Meeting Expectations: US FDA Communications Getting High Marks – Before COVID, At Least

FDA’s interactions with sponsors to support drug development activities are generally timely and effective – but industry still sees room for improvement in assuring ‘best practices’ are followed across all divisions.

Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved

The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.

Two Major Drugs Pushed Back In One Day - The Return Of A Stricter US FDA?

Knock-backs for Gilead/Galapagos and BioMarin are a surprise, and could be a sign of the FDA reasserting its 'gold standard' approach to safety and efficacy.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1133951

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel