New FDA reauthorization legislation being enacted by Congress will go way beyond a simple extension of user fees. The changes would reauthorize and amend the Prescription Drug User Fee, the Medical Device User Fee, the Best Pharmaceuticals for Children, and the Pediatric Research Equity Acts, among other regulations.
A BioWorld audio conference, “FDA Reauthorization Legislation: Essential Changes You Must Know Now,” scheduled Oct. 24, 2007 from 1 to 2:30 p.m., will explore what the changes mean to the industry and is a must for companies and regulatory professionals who need to make sure they are in compliance with the new legislative requirements.
Speakers Dan Kracov of Arnold & Porter, Kurt Karst of Hyman, Phelps & McNamara, and Wayne L. Pines of APCO Worldwide will guide listeners through the intricacies of the changes and highlight key concerns for the biotech and pharma industry.
The audio conference is just $299 per listening site. It includes presentation handouts and a half-hour Q&A session with the speakers. A CD (MP3 format) of the conference is also available. For more information or to register, call 800-688-2421 or 404-262-5474, and be sure to mention conference code T07480.