FDA Webinar: Draft GFI On Expedited Programs For Serious Conditions Drugs And Biologics - August 5, 2013
On August 5, 2013, FDA presented a webinar on a new draft guidance entitled "Draft Guidance For Industry On Expedited Programs For Serious Conditions Drugs And Biologics."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.
Draft GFI: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
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
PRESENTERS:
Stephanie Shapley
Health Science Policy Analyst
Office of Medical Policy
Brutrinia Cain
Regulatory Counsel
Office of Medical Policy
Presentation Information
Resources
- Archive of Past Webinars: http://www.fda.gov/Training/GuidanceWebinars/default.htm
If you have never attended a Connect Pro meeting before, please test your connection before the lecture by following this link: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm