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The first-in-a-series of Guidance Webinars presented an overview of the draft guidance Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring and provided a real-time question and answer session with the guidance's primary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:
Guidance Webinars can be accessed at: https://collaboration.fda.gov/guidancewebinars.
Contact Nicole.Silva@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FDA Webinar: Draft Guidance: Use of an Electronic Informed Consent in Clinical Investigations Questions and Answers – April 20, 2015 FDA Webinar: Draft Guidance for Industry (GFI) Uncomplicated Gonorrhea: Developing Drugs for Treatment - September 11, 2014 FDA Webinar: Guidance for Industry Chronic Fatigue Syndrome/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Draft GFI On Rheumatoid Arthritis - Developing Drug Products For Treatment; Availability – July 25, 2013 FDA Webinar: Draft Guidance For Industry On Alzheimer’s Disease: Developing Drugs For The Treatment Of Early Stage Disease; Availability - March 28, 2013 FDA Webinar: Webinar Draft GFI On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[ARCHIVED] 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[ARCHIVED] 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