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

US FDA Loss In Device Case Might Have Implications For Agency’s Work On Off-Label Rx Promotion

Executive Summary

While the statutes at issue in the case, which revolved around banning just one use of a medical device, do not govern drugs, experts on FDA law said the decision addressing a product’s intended use and regulation of the practice of medicine could have some impact on the agency’s Rx oversight powers.

You may also be interested in...



US FDA Advertising Citations Remain Rare In 2018

With only seven letters last year, Office of Prescription Drug Promotion appears to be continuing its enforcement retrenchment as agency reconsiders its approach to Rx communications.

COVID Vaccine BLA Review ‘Sprint’: Elevating Marks Role Could Have Drawbacks

US FDA veterans offered varying opinions as to the benefits and risks of the CBER director taking on a more hands-on role in reviewing Pfizer’s COVID-19 vaccine. The move was called unusual, but not inappropriate; some said it should be monitored closely to ensure review staff’s judgements are not pushed aside.

FDA’s Pazdur Believes ‘Advanced Research’ Project Could Address Trial ‘Wastefulness’

ARPA-H could be a solution to some of FDA’s long-running complaints about US clinical trial infrastructure, the agency's cancer chief says.

Topics

UsernamePublicRestriction

Register

PS144633

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