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

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New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.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



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.

US FDA Exploring Options To Improve Study Of Drugs In Elderly

New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.

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