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

PMA/AMA DISCUSSIONS ON USE OF OUTSIDE PHYSICIANS IN FDA DRUG APPROVAL PROCESS

Executive Summary

PMA/AMA DISCUSSIONS ON USE OF OUTSIDE PHYSICIANS IN FDA DRUG APPROVAL PROCESS are under way; the two groups met to discuss the issue on June 27. The use of outside medical expertise to speed up NDA reviews has been endorsed in concept by both FDA Com. Young and HHS Secty. Bowen. The June 27 meeting between the Pharmaceuical Mfrs. Assn. and the American Medical Assn. was the first time the idea has been discussed directly by the two groups. The two organizations reportedly discussed the possibility of physician residency or internship programs at FDA, recruitment of physicians for full-time positions, and the use of retired physicians to assist in the NDA review process. The idea of recruiting outside expertise to FDA to assist in NDA reviews first surfaced in Com. Young's Action Plan, released last July. The plan proposed a fellowship program to bring in academic scientists on a part-time basis. The plan also noted that FDA would seek to increase the use of consultants and try to recruit full-time scientists to carry out both scientific research and regulatory activities. HHS Secty. Bowen expressed interest in the use of retired MDs in the NDA review process at PMA's annual meeting in April ("The Pink Sheet" April 14, p. 12). PMA's committee to study improvements in FDA's approval process plans to meet with AMA again and then with FDA. The committee, headed by Roche's Irv Lerner, has been meeting with FDA to discuss the NDA review process since last July. FDA has also met with representatives from the Institute of Medicine to discuss that group's possible role in NDA reviews ("The Pink Sheet" Oct. 7, T&G-1).

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

MT125529

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