Drug Information Update - FDA Webinar: Draft GFI On Expedited Programs For Serious Conditions Drugs And Biologics - August 5, 2013

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

---

On August 5, 2013, from 10:00 AM - 11:00 AM (EDT), FDA will present a webinar on a new draft guidance entitled "Draft Guidance For Industry On Expedited Programs For Serious Conditions Drugs And Biologics."

 

The webinar will provide an opportunity to learn about the guidance from individuals involved in its preparation. It is 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

For more information please visit: FDA Webinar