Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Complete Response Letters: US FDA Tells Congress Broader Disclosures To Sponsors Could Be ‘Chilling’

Executive Summary

A lengthy hearing that addressed everything from Aduhelm to advanced manufacturing serves as the formal kick off of the user fee reauthorization season and offers a preview of many possible FDA reforms that House members could seek to include in the legislation.

You may also be interested in...



US FDA’s Califf Says Publishing Complete Response Letters Could Help Fight Misinformation

But the commissioner also said proponents of releasing CRs may be making too much of the idea, because there are few CRs actually issued.

Complete Response Letters: Industry Prefers Communication Before Rather Than Docs After

Rep. Dunn’s idea would be a return to prior agency practice; the documents are currently considered exempt from disclosure.

US FDA Accelerated Approvals Could Expire Under New Legislation, But Big Loophole Included

The bill, some version of which is undoubtedly destined for the FDA user fee package, also would codify existing labeling guidance for products cleared through the pathway.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145640

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