FDA Guidance Webinar Series

FDA's Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders. The webinar series are free to the public and the past webinars are achieved for free access. These webinars are presented by senior FDA officers and the author/coauthor of the issued FDA guidance.

FDA's Guidance Webinar series

Since 2011, the following webinars have been conducted:

• CDER Small Business Webinar on Stability Guidance for ANDAs, and draft Questions and Answers guidance – considerations – November 4, 2013
• FDA Webinar: 60-Day Draft GFI On Antibacterial Therapies For Patients With Unmet Medical Need For The Treatment Of Serious Bacterial Diseases – September 27, 2013
• FDA Webinar: Draft GFI On Expedited Programs For Serious Conditions Drugs And Biologics - August 5, 2013
• FDA Webinar: Webinar Draft GFI on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Availability - July 25, 2013
• FDA Webinar: Webinar Draft GFI On Rheumatoid Arthritis - Developing Drug Products For Treatment; Availability – July 25, 2013
• FDA Webinar: Draft Guidance For Industry On Alzheimer’s Disease: Developing Drugs For The Treatment Of Early Stage Disease; Availability - March 28, 2013
• FDA Webinar: Webinar Draft GFI On Enrichment Strategies For Clinical Trials To Support Approval Of Human Drugs And Biological Products – March 25, 2013
• FDA Webinar: New Draft Guidance on "FDA Guidance for Industry Webinar on Draft Guidance Vaginal Microbicides: Development for the Prevention of HIV Infection" - January 22, 2013
• FDA Webinar: 60-Day Draft Guidance on Using an Endpoint to Support Accelerated Approval of Drugs to Treat Early-Stage Breast Cancer - June 28, 2012
• FDA Webinar: New Draft Guidance on Safety Data Collection - March 27, 2012
• Guidance Webinar: Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring - October 24, 2011