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’s Funding Bridle: House Demands Opioid Guidance, Limits Compounding Boost

This article was originally published in The Pink Sheet Daily

Executive Summary

Senate appears on track to fund agency without serious caveats, setting up a potentially contentious conference.

You may also be interested in...



FDA’s Regulatory Rock And Hard Place: How To Handle Draft Guidances

Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.

FDA Opioid Guidance Is Silent On Generics, Cautions That Addicts Can Erase Labeling

Draft guidance on abuse-deterrent opioids notes that labeling claims may be revised if abusers outwit the abuse-resistant technology; the agency’s evaluation of generic-related citizen petitions continues.

Drug Review Times Are Not Shortened Much By Single Expedited Review Designation

Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.

Topics

Related Companies

UsernamePublicRestriction

Register

PS077232

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