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

Not So Fast: Trump Team Paints US FDA Review Times As Too Slow

Executive Summary

New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.

You may also be interested in...



US FDA’s Unapproved Drugs Initiative Comes Back To Life, With New Enforcement Guidance On Its Way

Longstanding compliance policy program aimed at getting marketed but unapproved drugs through the NDA/ANDA pathway is reinstated because its termination by the Trump Administration was ‘legally and factually inaccurate’; some experts want FDA to consider program’s impact on drug pricing as it re-establishes the initiative.

FDA Chief Counsel Stacy Cline Amin Guided Agency Through COVID-19 EUAs And Guidances

Amin leaves after two-year stint, but Trump administration chaos continues as HHS names a different replacement chief counsel than FDA did earlier in the day. James Lawrence is tapped to be FDA's top lawyer and will presumably help speed a number of regulatory changes at the agency.  

Some Long-Standing FDA Regs Face Mandatory Review Or Rescission Under New HHS Rule

Among those judged eligible are FDA rules governing adverse event reporting and the Unique Device Identification System.

Topics

UsernamePublicRestriction

Register

PS143605

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