On March 27, 2012, FDA presented a webinar on a new draft guidance entitled "Determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations."
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.
Download Presentation Slides: New Draft Guidance on Safety Data Collection (PDF - 123KB)
View Presentation Here: https://collaboration.fda.gov/p42291115/