Training and Continuing Education
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The first-in-a-series of Guidance Webinars presented an overview of the draft guidance Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring and provided a real-time question and answer session with the guidance's primary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 Neoadjvant 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:
Guidance Webinars can be accessed at: https://collaboration.fda.gov/guidancewebinars.
Contact Jeffery.Rexrode@fda.hhs.gov for technical problems. 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.
FDA Webinar: New Draft Guidance on "FDA Guidance for Industry Webinar on Draft Guidance Vaginal Microbicides: Development for the Prevention of HIV Infection" - January 22, 2013 FDA Webinar: 60-Day Draft Guidance on Using an Endpoint to Support Accelerated Approval of Drugs to Treat Early-Stage Breast Cancer - June 28, 2012 FDA Webinar: New Draft Guidance on Safety Data Collection - March 27, 2012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