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

FDA PRODUCT REVIEW POLICY FOR NDAs/ANDAs OF SUSPECT "INTEGRITY"

Executive Summary

FDA PRODUCT REVIEW POLICY FOR NDAs/ANDAs OF SUSPECT "INTEGRITY" will be published within the next week or two in the Federal Register. FDA Acting Commissioner James Benson referred to the proposed policy in a Sept. 21 letter to House Energy & Commerce/Oversight Subcommittee Chairman John Dingell (D-Mich.). Benson's letter was a response to a Sept. 14 letter from Dingell concerning the agency's suspension of reviews of all American Cyanamid new animal drug applications following FDA's discovery of possible clinical data manipulation. In that letter, Dingell asked why FDA had not adopted a policy for suspending reviews of human drug applications of firms involved in fraud or corruption until the companies in question could assure the validity of the data. Benson told Dingell that the "same policy has been in force throughout the generic drugs investigation." He added that while FDA currently has no statutory authority to prevent sponsors from receiving product reviews and approvals, the agency is developing "a new compliance policy." The new policy represents "an effort to elucidate for the benefit of all FDA-regulated industries the regulatory measures the agency may employ when the integrity of the data in product applications is undermined," Benson said. "This proposed policy will set forth the conditions under which the agency will defer both product approvals and substantive data reviews." The new compliance policy also will tell firms how to "rehabilitate" tainted applications. The FDA official added that the purpose of the deferrals "would be to ensure that the data in pending applications are valid prior to the agency's reliance on the data to determine safety and efficacy after fraud and/or improper conduct such as payment of illegal gratuities has occurred."

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

LL005491

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