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

Free speech comment deadline extended

Executive Summary

FDA grants 45-day extension for comments on First Amendment issues and agency regulation of commercial speech. Comments will be due Sept. 13, rebuttal comments Oct. 28. The extension comes "in response to several requests from the public," agency says. Pfizer and Pharmacia are among those who asked FDA for additional time; the companies requested a 60-day extension (1"The Pink Sheet" Jun. 24, In Brief). FDA solicits comments on free speech in July 3 Journal of the American Medical Association "News and Analysis" section...

You may also be interested in...



Free speech can wait?

FDA should extend the timeline for responses to a request-for-comment on First Amendment issues, Pfizer and the Pharmaceutical Research & Manufacturers of America tells the agency. "As an institutional matter, Pfizer is committing substantial time and resources to reviewing and responding to the notice," the company said. "Pfizer intends to consult with various experts concerning many of these questions to prepare more fully informed comments." FDA asked for comments by July 30 on the legal basis for its promotional rules with another 45-days for rebuttals (1"The Pink Sheet" May 20, p. 14). PhRMA and Pfizer are asking for a 60-day extension, which would move the final deadline back until the week after Election Day...

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials. 

UsernamePublicRestriction

Register

OM004674

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