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



Executive Summary

COMPUTERIZED NDAs: PMA URGES FDA TO CONTINUE ACCEPTING computer-assisted NDAs (CANDAs) from different systems. In March 1 comments, the Pharmaceutical Manufacturers Association said: "FDA must resist the temptation to decide prematurely upon an optimal technology before sufficient experience with different hardware/software configurations are obtained." The comments responded to an agency "guidance" on CANDA submissions, published in the Sept. 15 Federal Register. The guidance states that the filing of a CANDA is conditional on the reviewing division's willingness to accept the application ("The Pink Sheet" Sept. 19, p. 7), PMA noted. The association emphasized its concern that reviewers may refuse applications because they are unfamiliar with certain systems and thereby establish a de facto standard. "Just as FDA encourages drug sponsors to explore the use of CANDAs and to explore new systems and technologies," the association said, "PMA similarly encourages FDA to ensure that its reviewers are equally committed to accepting this diversity and working with drug sponsors to maximize their experiences with the variety current technology offers to both sponsors and reviewers in CANDA functionality." "At some point," PMA noted, "a decision will need to be made regarding a 'uniform approach' to a CANDA system." As a result, "it must be recognized that such a decision will ultimately be based upon prevailing technology at a specific point in time and based upon the ability of that technology to provide FDA reviewers with reasonable capabilities to fulfill their regulatory obligations." PMA noted that FDA's efforts to explore use of computers in the drug approval process has relied to date on "sponsors loaning computer equipment to FDA in order to support these experimental projects." The association offered to help resolve the "logistical difficulties" presented by that arrangement. "We recognize that FDA will likely need to structure and implement a mechanism to allow the agency readily to identify resident equipment, the source of that equipment, and the application associated with that equipment, PMA and its members will continue to assist FDA in these efforts."

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




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