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

HHS Regulatory Reform Proposal Seen As Blunt Instrument That Could Burden Industry and Agencies

Executive Summary

Most FDA and CMS rules would sunset after 10 years unless action is taken by the agency under a new HHS proposed rule designed to enforce retrospective regulation review. Some experts worry this could allow an administration to skirt traditional notice and comment periods before rule rescissions. The implementation of the rule would likely look very different at FDA than at CMS, experts added.

You may also be interested in...



White House Advances War On 'Guidance'; FDA Not Target, But May Feel Ripple Effects

US FDA's efforts to enforce against regenerative medicine and other gray market products might be collateral damage in Trump administration's latest attack on the perceived abuse of powers by regulatory agencies.

US FDA Likely Not 'Significant', Could Be Mostly Spared From Trump's Regulation-Slashing Order

But even though executive order that requires regulatory off sets may only have limited application to FDA, limited, experts warn that it still could prove extremely unwieldly to implement.

US FDA’s Unapproved Drug Initiative Nixed, But Without Agency Buy-In Demise May Be Short-Lived

Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.

Topics

UsernamePublicRestriction

Register

ID036688

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