Search for FDA Guidance Documents > Minutes of Institutional Review Board (IRB) Meetings - Draft Guidance for Institutions and IRBs

Search for FDA Guidance Documents > Minutes of Institutional Review Board (IRB) Meetings - Draft Guidance for Institutions and IRBs

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) are extending the comment period for the joint draft guidance entitled “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.” A notice of availability requesting comments on the draft guidance document previously appeared in the Federal Register of November 5, 2015. The Agencies are taking the initiative to extend the comment period for an additional 30 days because the timing of the due date for comments intersects with comment periods on other Federal Register documents requiring review by the same group of stakeholders. This extension will allow interested persons additional time to submit comments. This joint draft guidance is available on FDA's website at http://www.fda.gov/RegulatoryInformation/Guidances/ucm470046.htm, and OHRP’s website at http://www.hhs.gov/ohrp/newsroom/rfc/index.html.

 Comments are due by February 3, 2016.