Advisory Committee Meeting | Virtual
Event Title
UPDATED INFORMATION: October 17 – 19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee
October 17 - 19, 2022
- Date:
- October 17 - 19, 2022
- Day1:
- - ET
- Day2:
- - ET
- Day3:
- - ET
What is an advisory committee?
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.
Official Federal Register Notice Publication
Link to Docket No. FDA-2020-N-2029
Note: Presentation slides were updated to reflect what was shown during the hearing.
UPDATED INFORMATION (as of October 19, 2022):
The start time for October 19, 2022 (Day 3) has changed to 8:30 a.m. Eastern Time.
All other information remains the same.
UPDATED INFORMATION (as of October 16, 2022):
The start time for October 18, 2022 (Day 2) has changed to 8:20 a.m. Eastern Time.
All other information remains the same.
UPDATED INFORMATION (as of August 29, 2022):
Public Participation Information:
The deadline for submitting requests to make a formal presentation or present oral comments during the session for public participation has been extended to September 14, 2022.
Details have been provided in the Federal Register. Members of the public, including ANDA holders, wishing to make a formal presentation at the hearing must register at the following link by 5:00 p.m. EDT on September 14, 2022: https://www.surveymonkey.com/r/B72THCF. To complete your request for an opportunity to make a presentation at the hearing, you must also submit a comment to the docket for this hearing matter (DOCKET NO. FDA-2020-N-2029) by 11:59 p.m. EDT on September 14, 2022, and clearly indicate in the heading and/or cover page that your comment is a “Request for Oral Presentation.”
All other information remains the same.
ORIGINAL INFORMATION:
Center for Drug Evaluation and Research
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.
Agenda
The Office of the Commissioner is conducting a hearing under 21 CFR 314.530 on the Center of Drug Evaluation and Research's proposal to withdraw accelerated approval of Makena (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL)). As part of the hearing process, the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (the Committee) will discuss whether a confirmatory trial verified the clinical benefit of Makena and whether available evidence demonstrates that Makena is effective for its approved indication, which is to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The Committee will also discuss whether FDA should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.
The hearing will be held in a virtual format. Details will be provided in a future communication in the Federal Register. Members of the public, including ANDA holders, wishing to make a formal presentation at the hearing must register at the following link by 5:00 p.m. EDT on September 6, 2022: https://www.surveymonkey.com/r/B72THCF. To complete your request for an opportunity to make a presentation at the hearing, you must also submit a comment to the docket for this hearing matter (DOCKET NO. FDA-2020-N-2029) by 11:59 p.m. EDT on September 6, 2022, and clearly indicate in the heading and/or cover page that your comment is a “Request for Oral Presentation.”
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).