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          FDA Webinar: Draft GFI On Expedited Programs For Serious Conditions Drugs And Biologics - August 5, 2013Drugs FDA Webinar: Draft GFI On Expedited Programs For Serious Conditions Drugs And Biologics - August 5, 2013
  
  	
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    PrintOn August 5, 2013, FDA presented a webinar on a new draft guidance entitled "Draft Guidance For Industry On Expedited Programs For Serious Conditions Drugs And Biologics."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

FR Notice: https://www.federalregister.gov/articles/2013/06/26/2013-15250/draft-guidance-for-industry-on-expedited-programs-for-serious-conditions-drugs-and-biologics

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

Expedited Programs For Serious Conditions Drugs And Biologics WebinarResources

Archive of Past Webinars: http://www.fda.gov/Training/GuidanceWebinars/default.htmIf 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

                                                                                  Content current as of:
      10/08/2015Drugs

          
                        


                        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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