The Open Public Hearing at FDA Advisory Committee Meetings

… ensuring FDA has access to such advice through the public hearing process as provided in existing laws and regulations. …  Every advisory committee meeting includes an open public hearing (OPH) session, during which interested persons may … of the Commissioner … Guidance Document … The Open Public Hearing at FDA Advisory Committee Meetings: Guidance for the …

Remarks by Acting Commissioner Ned Sharpless at the FDA Public Hearing on The Future of Biosimilar Insulin - 05/13/2019

… thank you for joining us for today’s very important Public Hearing. The world of public health has never been as … treatments and devices.   The subject of today’s public hearing -- facilitating the efficient development of … And we’ve taken some important steps.  Today’s Public Hearing is another key step – the opportunity to hear from …

CPG Sec. 140.100 Seizure of Books that Constitute Misleading Labeling

… by section 304 of the Act to seize without a prior hearing may be argued to be an unconstitutional prior … *against the product and an injunction to halt, after a hearing, the misuse of the book.* *Material between asterisks …

Advisory Committees Give FDA Critical Advice and the Public a Voice

… people to share their views during the open public hearing or by submitting comments to the open docket. … Committees Guidelines for Speakers at the Open Public Hearing of an FDA Advisory Committee Meeting Calendar of …

FDA Roundup: August 1, 2023

… violated the 2010 injunction and scheduled an evidentiary hearing regarding whether their noncompliance was justified. Prior to the hearing, the parties negotiated the consent decree, which, …

Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement - 06/05/2024

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person notified interested …

Vaccines and Related Biological Products Advisory Committee October 2, 2020 Meeting Announcement - 10/02/2020

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Blood Products Advisory Committee December 8, 2022 Meeting Announcement - 12/08/2022

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement - 03/10/2022

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement - 03/04/2020

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

CPG Sec. 160.100 Regulatory Actions and Small Business

… petitions to the Agency. Providing information on Agency hearing procedures and how small businesses can participate …

Blood Products Advisory Committee May 9, 2024 Meeting Announcement - 05/09/2024

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee October 5, 2023 Meeting Announcement - 10/05/2023

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement - 10/06/2022

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

POSTPONED - Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement - 05/16/2024

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Announcement - 06/15/2023

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement - 10/31/2023

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Announcement - 10/26/2021

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Announcement - 06/10/2021

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting Announcement - 03/03/2022

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement - 12/10/2020

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement - 10/22/2020

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement - 02/26/2021

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement - 09/17/2021

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …

Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Announcement - 10/14/2021

… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …