FDA Webinar: New Draft Guidance on Safety Data Collection - March 27, 2012
The webinar provided an opportunity to learn about the guidance from individuals involved in its preparation. It was also intended to encourage the submission of questions or comments while the guidance is still in draft form.
The guidance addresses the circumstances in which it may be acceptable to acquire a reduced amount of safety information during clinical trials. FDA webinar participants will include Dr. Robert Temple, Dr. Mary Ross Southworth, and Dr. Amna Ibrahim.