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

US FDA Center Directors Should Not Influence Adcomm Votes Or Overrule Scientific Staff, Coalition Says

Executive Summary

In a letter to Commissioner Robert Califf, the Patient, Consumer and Public Health Coalition says medical product center directors and other senior staff should refrain from trying to sway advisory committee votes and be reminded that overruling decisions of their own scientific staff undermines the public trust.

You may also be interested in...



US FDA Could Have Millions Of Advisors, If Not For Current Law, Califf Says

Commissioner Califf says the technology exists and the idea would allow the agency to be more nimble, but the Paperwork Reduction Act makes the process difficult.

Elevidys And The EMBARK Trial: Is Another Advisory Committee Meeting Coming?

Sarepta says another public meeting is not necessary to expand the label for its DMD gene therapy, but the missed primary endpoint may require input from experts outside the FDA, and the situation renews the spotlight on CBER Director Peter Marks and his initial approval decision.

US FDA Chief Scientist Wants To Make Advisory Committee Participation Easier

Namandjé Bumpus says hybrid panels are the future and stakeholders should not oversimplify coming committee reform into just a voting or non-voting meeting binary.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148566

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