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

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...



Keeping Track: US FDA Approves Heron’s Zynrelef In Post-Op Pain; Amgen/AZ Submit Tezepelumab For Severe Asthma

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Heron Overcomes Two CRLs To Win Zynrelef Approval In Post-Op Pain

The combination of bupivacaine and meloxicam will be priced at a discount to Exparel, with Heron predicting rapid uptake. Label limited to three surgery types, but analysts expect off-label use.

US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics

FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS142673

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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