On August 5, 2013, FDA presented a webinar on a new draft guidance entitled "Draft Guidance For Industry On Expedited Programs For Serious Conditions Drugs And Biologics."
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.
Questions may be submitted to docket so that they can be formally processed by FDA.
Docket No. FDA-2013-D-0575 which can be found at: www.regulations.gov
Date FR NOA: 06/26/2013
Comment Period Closes: 08/26/2013
- Archive of Past Webinars: http://www.fda.gov/Training/GuidanceWebinars/default.htm