Understanding FDA Regulatory Requirements Involved in Developing and Commercializing Medical Devices and Drugs
|Start:||11/2/2012 at 1:30PM|
|End:||11/2/2012 at 2:30PM|
|Location:||DeBartolo Hall, Room 208|
Researchers and start-up/early stage companies developing and studying new medical devices and drugs face many FDA regulatory requirements applicable to their activities. These include "good laboratory practices" for non-clinical research, clinical trial obligations, design control requirements for many medical devices, and data development requirements for marketing applications to FDA. Understanding the applicable requirements is crucial to successful and compliant product development and business planning. This presentation will explore many of the important requirements and offer practical compliance advice.
Our speaker is Neil O'Flaherty (ND, '87), the principal attorney at Olsson Frank Weeda in Washington, D.C.