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

FDA in the Shutdown: Drug Center Stays Open (Mostly); Ben Venue Does Not

This article was originally published in RPM Report

Executive Summary

New drug approvals continued during the partial government shutdown, as user fees helped keep most of the FDA review functions running smoothly. The drug center did face some unusual challenges, including responding to a major manufacturing shutdown (by Ben Venue) – and to speculation about a leadership change at the drug center.

You may also be interested in...



FDA In Twilight: Gov’t Shutdown Has Not Slowed Rx Operations Too Visibly Yet

Shutdown puts API shipments on a slow boat, but reviews of existing products can proceed with carry-over funds, even as new applications cannot be filed. CDC has largely halted its influenza program and NIH has ceased enrolling new patients in its clinical center.

FDA’s First “Program” Reviews: Fast Approvals, But Still Some Surprises

The Food & Drug Administration is approving the first products under the new PDUVA V review process. The Program, as it is known, gives FDA an extra two months with an application in exchange for additional meetings for sponsors. It’s designed to help reduce the number of late-cycle “surprises.” There have been a few hiccups, but so far, it appears to be doing just that.

Virtual Advisory Committees: US FDA Clears A Big Test With OxyContin Meeting

Meeting to address opioid abuse crisis was also a trial of whether FDA could conduct important public business using online-only technology.

Topics

Related Companies

UsernamePublicRestriction

Register

LL111109

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