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

Off-Label Use: US FDA Backs Away From ‘Totality Of Evidence’ Standard In Proposed Reg

Executive Summary

New proposed rule says a manufacturer’s knowledge of the unapproved use of a product does not alone determine intended use. Former FDA lawyer says rule could set off fireworks over the scope of what the agency considers evidence of off-label use.

You may also be interested in...



FDA Chief Counsel Defends COVID-19 EUAs, Praises ‘Moral Strength’ Of Commissioner Hahn

Stacy Cline Amin says authorizing or licensing a COVID-19 vaccine is ‘perhaps the most consequential action the agency will ever take.’ Speaking at FDLI conference, she notes that standards for vaccine EUA will be higher than what has been required for therapeutics.

US FDA’s First Amendment Defense

Before taking over the US health department, Alex Azar helped bring landmark litigation challenging the scope of FDA’s regulatory authority under the First Amendment. Now his tenure is ending with a First Amendment defense of the agency.

'Intended Use' Rule: US FDA May Toss Its 'Totality Of Evidence' Standard

Pharma and device industries had complained that rule is overbroad, violates the First Amendment and would increase company exposure to liability.

Related Content

Topics

UsernamePublicRestriction

Register

ID1132356

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