While the FDA’s dispute resolution process (the agency's version of an appeals court) is used to get a review of both scientific and procedural actions, IND/NDA decisions and warning letters are the most commonly challenged issues.
Just recently, Labopharm appealed an approvable letter for a drug, claiming that the FDA had previously requested additional data analysis that proved its effectiveness and met approval conditions. An expected action date has been set for Jan. 2, 2009.
TMJ Implants, in another instance, objected to an inspection that resulted in a Form 483 and later a warning letter that cited failure to file 17 adverse event reports under MDR regulations. TMJ claimed the events were not reportable under MDR. TMJ won the right to appeal, although they lost the case.
In both instances these companies knew how to properly maneuver through the dispute resolution process.
Knowing when to confront an FDA action and how to take the proper steps towards filing for a request to challenge that action can determine whether or not a review will even be granted.
As companies contend with complete response letters and and an increase in FDA crackdowns on facility inspections, there will be more challenges to negative FDA actions — meaning it’s more important than ever to gain a complete understanding of the dispute resolution process.
Regulatory expert Steven Hoff will walk you through the formal and informal processes to request a review. He’ll explain whether or not you should make a request. And he’ll follow-up with lessons learned through case studies on firms that have both succeeded and failed.
Order now for your entire team to listen in and discover:
Order now and gain a thorough understanding of how and when to use the FDA’s dispute resolution process. Avoid having your request rejected — take advantage of the processes available to you to get your case in front of the FDA.
Steven Hoff has worked in biomedical research for more than 30 years, including 17 years of experience in regulatory affairs. He has been involved in numerous INDs, NDAs and supplemental NDAs, along with 510(k)s for devices. Steven has coordinated major meetings and teleconferences with the FDA, prepared the associated briefing documents and performed due diligence efforts. His background includes 12 years of academic research in the areas of cell biology, neuroscience, pharmacology and oncology, along with 25 years teaching medical pharmacology. Steven has served on the faculty for Regulatory Master’s Degree at Purdue University, School of Pharmacy; as co-editor for the RAPS Fundamentals of U.S. Regulatory Affairs in 2003 and 2005; and on the editorial board of the Drug Information Association Journal from 2006 to present.
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