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The first-in-a-series of Guidance Webinars presented an overview of the draft guidance Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring and provided a real-time question and answer session with the guidance's primary authors.

Additional Recorded Webinars

• Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations
• Pathologic Complete Response in Neoadjuvant Treatment of High Risk Early-Stage Breast Cancer:  Use as an Endpoint to Support Accelerated Approval

Archived webinars, transcripts, and audience questions are available in the list below: 

FDA Guidance Webinars Online-Access Instructions: Access Guidance Webinars

Each webinar will be recorded and streaming links to access the recordings will be available after each session, along with relevant meeting materials on this website.

2011 - 2015 webinars are archived. To view them, please see the FDA Archive
To view the webinars, copy and paste the web address starting with https:// into a web browser.

 

Past Webinars

• FDA Webinar: Draft Guidance: Use of an Electronic Informed Consent in Clinical Investigations Questions and Answers - April 20, 2015
• FDA Webinar: Draft Guidance for Industry (GFI) Uncomplicated Gonorrhea: Developing Drugs for Treatment - September 11, 2014
• FDA Webinar: Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment - April 23, 2014
• FDA Webinar: Final GFI: Electronic Source Data In Clinical Investigations (Procedural) - January 29, 2014
• 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• FDA Webinar: Draft Guidance For Industry On Alzheimers Disease: Developing Drugs For The Treatment Of Early Stage Disease; Availability - March 28, 2013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