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          FDA Webinar: New Draft Guidance on Safety Data Collection - March 27, 2012Drugs FDA Webinar: New Draft Guidance on Safety Data Collection - March 27, 2012
  
  	
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    PrintOn March 27, 2012, FDA presented a webinar on a new draft guidance entitled "Determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations."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.

View Presentation Here: https://collaboration.fda.gov/p42291115/

                                                                                  Content current as of:
      10/06/2015Drugs

          
                        


                        Regulatory Science Research and Education
          Development & Approval Process | Drugs
          Drug Safety and Availability
          Emergency Preparedness | Drugs
          Guidance, Compliance, & Regulatory Information
          News & Events for Human Drugs
          Resources | Drugs
          Science and Research | Drugs
 
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