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UPDATED INFORMATION: October 17 – 19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee - 10/17/2022
… y-committee-calendar/updated-information-october-17-19-2022-hearing-announcement-involving-obstetrics-reproductive-and … … slides were updated to reflect what was shown during the hearing. UPDATED INFORMATION (as of October 19, 2022): The … ANDA holders, wishing to make a formal presentation at the hearing must register at the following link by 5:00 p.m. EDT …
UPDATED PUBLIC PARTICIPATION INFORMATION: October 17 -19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee - 10/17/2022
… updated-public-participation-information-october-17-19-2022-hearing-announcement-involving … UPDATED INFORMATION (as of … 2 p.m. to 4 p.m. Eastern Time on the first day of the hearing and from 8 a.m. to 10 a.m. on the second day. Persons interested in participating in the hearing by making an oral presentation during the 4 hours …
UPDATED MEETING TIME AND OPEN PUBLIC HEARING TIME: March 30, 2022: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement - 03/30/2022
… ugs-advisory-committee/updated-meeting-time-and-open-public-hearing-time-march-30-2022-meeting-peripheral-and-central … … to 10:00 a.m. – 5:00 p.m. Additionally, the Open Public Hearing time has changed from 1:30 p.m. – 2:30 p.m. to 1:55 … reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the …
UPDATED PUBLIC PARTICIPATION INFORMATION: September 21, 2023 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement - 09/21/2023
… request under 21 CFR 12.32(b)(3)(ii) for a public hearing before an advisory committee in lieu of a formal evidentiary hearing. Intarcia requested a public hearing before an advisory committee on CDER’s proposal to …
April 25, 2016: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee - 04/24/2016
… 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 … reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the …
AMENDMENT OF NOTICE: March 1, 2018 - Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 03/01/2018
… make a presentation separate from the general Open Public Hearing; time slots on March 1, 2018, between approximately … 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 …
April 12, 2016: Pediatric Advisory Committee Meeting Announcement - 04/12/2016
… drugs. Prior to the safety reviews and the open public hearing (see later in this section for further information), … 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 …
September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement - 09/10/2019
… 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 … Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by …
December 4-5, 2018: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 12/04/2018 - 12/05/2018
… make a presentation separate from the general open public hearing; time slots are available on December 5, 2018. … 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 …
November 15, 2018: Patient Engagement Advisory Committee Meeting Announcement - 11/15/2018
… 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 … Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by …
Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement - 05/08/2020
… open sessions of the meeting including the Open Public Hearing (OPH) of the meeting can be accessed through the … 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 …
March 14, 2024: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 03/14/2024
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
October 22, 2020: Patient Engagement Advisory Committee 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 … Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by …
October 6, 2021: Patient Engagement Advisory Committee Meeting Announcement - 10/06/2021
… 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 … Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by …
UPDATED INFORMATION : November 22, 2022: Meeting of the Oncologic Drugs Advisory Committee Announcement - 11/22/2022
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
July 12-13, 2022: Patient Engagement Advisory Committee Meeting Announcement - 07/12/2022
… 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 … Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by …
April 12, 2024 Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 04/12/2024
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
UPDATED INFORMATION: April 17, 2023: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement - 04/17/2023
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
May 19, 2023: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement - 05/19/2023
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
October 4, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 10/04/2023
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
May 22, 2024: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement - 05/22/2024
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
UPDATED AGENDA INFORMATION: October 28, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 10/28/2022
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
June 8, 2023: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement - 06/08/2023
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …
June 16, 2023: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement - 06/16/2023
… 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 … the Information Line for up-to-date information on this hearing. For press inquiries, please contact the Office of …