Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Free speech can wait?

Executive Summary

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...

You may also be interested in...



Free speech comment deadline extended

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...

FDA Seeks Comment On Ad Regs: Can Rx Be More Regulated Than OTCs?

FDA is requesting comment on the legal underpinnings for arguing that promotions of prescription drugs can be more tightly regulated than those for other products

Cosmetic And Personal Care Trademark Review: 16 April

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS040046

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