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On August 5, 2013, from 10:00 AM - 11:00 AM (EDT), FDA will present a webinar on a new draft guidance entitled "Draft Guidance For Industry On Expedited Programs For Serious Conditions Drugs And Biologics."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/ GuidanceComplianceRegulatoryIn formation/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
Date FR NOA: 06/26/2013
Comment Period Closes: 08/26/2013
For more information please visit: FDA Webinar