Medtech Insight 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


Lawmakers say warning letter appeals process should be reviewed

This article was originally published in The Silver Sheet

Executive Summary

FDA needs to review its enforcement dispute resolution process, two leading Republicans on the House Energy and Commerce Committee say. In a Nov. 14 letter, Joe Barton, R-Texas, and Ed Whitfield, R-Ky., ask FDA Commissioner Andrew von Eschenbach to "personally review how center directors monitor top disputes and controversies, and report back on management performance in this area and whether any further steps or actions will be taken to improve dispute resolution and priority setting of enforcement resources." Barton, the ranking Republican of the full committee, and Whitfield, the ranking member of the subcommittee on oversight and investigations, first inquired into FDA's warning letter appeals process in an April letter to von Eschenbach in response to the agency's actions against Colorado dental implant company TMJ Implants ("The Silver Sheet" May 2007)

You may also be interested in...

Dr Reddy's Adds To OTC Portfolio With Glenmark Deal

Dr Reddy's is poised to expand its OTC offering in Russia and certain CIS countries by snapping up a basket of allergy brands from fellow Indian firm Glenmark.

Sandoz Launches US Awareness Campaign

Sandoz has launched an awareness campaign under the banner of “Ask For Generics” in the US. The initiative is aiming to educate stakeholders on the benefits of generics and their quality, safety and efficacy.

EU Plans IP Law Shake-Up

European Commission proposals for strengthening intellectual property protections in the EU, particularly the supplementary protection certificate (SPC) system, have been broadly welcomed by Europe’s brand industry. But the medical NGO, MSF, says the SPC proposals run counter to the commission’s own efforts to improve access to medicines.





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