Scrip 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

FDA Deputy On CRLs: 'It's Not Our Property To Release'

Executive Summary

US FDA Principal Deputy Commissioner Rachel Sherman said during the BIO CEO & Investor conference that while investors and others would like to see complete response letters, the agency's hands are bound when it comes to their full release. Sherman also commented on FDA's focus for right-to-try legislation.

You may also be interested in...



What Does Rachel Sherman Think About Top FDA Regulatory Issues?

Speaking at the BIO CEO & Investor Conference, US agency's No. 2 official talks about compassionate use, opioids, clinical trial design, and the agency's succession plan.

Trump On Right-to-Try: Gottlieb's 'Heading It Up'?

Curious comment by president could place US FDA Commissioner in tough spot balancing his boss' priorities with his and staff's concerns about pending right-to-try legislation.

Complete Response Letters: US FDA Trying To Identify Subsets For Public Release

Agency want to identify a 'manageable' subset of letters for release in which drug approval was denied for reasons, such as safety concerns, that can help inform clinical practice and impact public health, Commissioner Gottlieb says, adding: 'I'm not sure that that's doable. I'm inclined to think that it might be.'

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

SC100410

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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