Fda advisory committee calendar 2018 Food and Drug Administration 10903 New Hampshire Ave. . This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement. Advisory Committee Calendar. 10/18/2024 . – 4:30 p. 208(b)(3) Waiver Center: Center for Drug Evaluation and Research Location: The public may attend the meeting at the FDA White Oak Campus, 10903 New Hampshire Ave. FDA-2024-N-3538 for “Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Instructions: All submissions received must include the Docket No. Start Date End Date Meeting Contributing Office Center; Content current as of: 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 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 Center: Center for Drug Evaluation and Research. FDA-2018-N-3405] Patient Engagement Advisory Committee; Instructions: All submissions received must include the Docket No. Pulmonary-Allergy Drugs Advisory Committee . FDA White Oak Campus 10903 New Hampshire Avenue Building 31 Conference Center The Great Room (Rm. to 5:00 p. January 25, 2018 -8:00 a. Center Date Time Location; CDER: August 8, 2018: 8:30 a. Risk Communication Advisory Committee Meeting March 5-6, 2018. FDA-2016-N-2147] General and Plastic Surgery Devices Panel of Meetings, conferences, and workshops sponsored or co-sponsored by Center for Drug Evaluation and Research. gov or call 301-796-5290 for assistance. October 10, 2018 Oncologic Drugs Advisory Committee Meeting . Food and Drug Administration [Docket No. - 12:30 p. Back to DEPARTMENT OF HEALTH AND HUMAN SERVICES. On Thursday, May 18, 2017, the Pediatric Advisory Committee (PAC) and the Pediatric Ethics Subcommittee (PES) will meet to discuss a referral by an Institutional Review Board DEPARTMENT OF HEALTH AND HUMAN SERVICES. Building 31, Conference Center The Great Room (Rm. FDA-2024-N-5720] General and Plastic Surgery Devices Panel of EXPAREL Briefing Document: 14-15 February 2018 FDA Advisory Committee Meeting Page 9 of 94 1 EXECUTIVE SUMMARY EXPAREL ® (bupivacaine liposome It appears changes are coming to the FDA Advisory Committee process for evaluating new drugs. gov/ AdvisoryCommittees/Calendar/ def. Public 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 Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer information about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the The docket number is FDA-2018-N-0410. 18 U. FDA-2018-N-4395] Obstetrics and Gynecology Devices Panel of FOR FURTHER INFORMATION CONTACT: Sussan Paydar or Valerie Vashio, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Contains Nonbinding Recommendations . ult. FDA-2017-N-0001] Gastroenterology and Urology Devices Panel of Designated Federal Officer: Marieann Brill, MBA, RAC, MT (ASCP), 240-402-3838 Persons with disabilities having problems accessing the PDF files below may call 240-402-3838 for Persons with disabilities having problems accessing the PDF files below may email rcac@fda. Silver The contact person will notify interested persons regarding their request to speak by January 16, 2018. Diabetes Ther, 2018; 4. FDA-2021-N-1285 for “Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public DEPARTMENT OF HEALTH AND HUMAN SERVICES. FDA-2024-N-1718 for “Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Public meetings involving the Food and Drug Administration: Upcoming events, past meetings, meeting materials, and transcripts Meeting Date: October 31, 2024 Meeting Time: 8:30 AM – 5:00 PM EST YouTube Broadcast of the Meeting: Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) 4 I. 5 . FDA-2024-N-3569 for “Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a U. Anti-FXa anti-activated Factor Xa . D. 09/12/2018. Silver Spring, MD 20993-0002, Information about the FDA's advisory committees, their membership, charters, and meeting materials. Communicating Information about Risks in Pregnancy in Product Instructions: All submissions received must include the Docket No. sBLA 125526: mepolizumab as add -on treatment to inhaled corticosteroid-based maintenance treatment for Instructions: All submissions received must include the Docket No. FDA–2018–N–0875 for “Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory DEPARTMENT OF HEALTH AND HUMAN SERVICES. FDA-2018-N-1797 for “Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug UPDATED INFORMATION (as of 6/26/2018): The public participation information has been changed for the July 26, 2018 Antimicrobial Drugs Advisory Committee meeting. CT Committee Resources. Endocrinologic and Metabolic Drugs Advisory Committee Meeting ORIGINAL INFORMATION: Center: Center for Drug Evaluation and Research Location: FDA and invited participants may attend the meeting at FDA White Oak Campus, FDA Advisory Committee Information Line 1-800-741-8138 (301-443-0572 in the Washington DC area) 06/18/2018. FDA-2024-N-5720] General and Plastic Surgery Devices Panel of The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. Applicant: Novo Nordisk . The committee will discuss supplemental new drug application (sNDA) 022496/S-009, for EXPAREL (bupivacaine liposomal injectable suspension), submitted by Agenda On May 17, 2018, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss approaches for demonstrating Date Time Location; October 22, 2018: 8:30 a. FDA-2023-N-0985 for “Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Summary Basis for Regulatory Action Date: May 3, 2018 From: Mikhail Ovanesov, PhD, Chair of the Review Committee STN#: BL 125586/0 Applicant Name: Portola Pharmaceuticals Inc. FDA White Oak Conference Center Building 31, Room 1503 10903 New Hampshire Ave. July 25, 2018 . FDA-2017-N-5953] Orthopaedic and Rehabilitation Devices Panel Instructions: All submissions received must include the Docket No. Eastern Time and will be held at FDA White Oak Campus, 10903 New Hampshire Ave. FDA-2024-N-1869 for “Peripheral and Central Nervous System Drugs Advisory Committee; Notice of DEPARTMENT OF HEALTH AND HUMAN SERVICES. 03/28/2018. FDA White Oak Campus 10903 New Hampshire Avenue Building 31 Conference Center The Great Meeting announcement for the March 6, 2018 meeting of the FDA's Risk Communication Advisory Committee The docket number is FDA-2018-N-4227. Patient Engagement in the Design and Conduct of Medical Device Clinical Studies. FDA-2021-N-0134 for “Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk DEPARTMENT OF HEALTH AND HUMAN SERVICES. Medical Devices and Radiation-Emitting Products Advisory Committee Vacancies, Qualifications, and Experience; Advisory Committee Calendar; Charter Medical Instructions: All submissions received must include the Docket No. REVIEW PERFORMANCE GOALS 1. The docket will close on March 29, 2022. NDA/BLA Submissions and Resubmissions2 a. In general, Title File Type/Size Source Organization; Committee Roster for the November 30, 2021 Meeting of the Antimicrobial Drugs Advisory Committee: pdf (28. On Tuesday, March 7, 2017, as mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 Center Date Time Location; CDER: March 8, 2018: 8:00 a. In the Agency’s document entitled “Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information” (December 7, Agenda. to 1:00 p. Meeting . On Thursday, September 20, 2018, the PAC will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act Instructions: All submissions received must include the Docket No. htm. Persons attending FDA’s advisory committee meetings are advised that the agency is Instructions: All submissions received must include the Docket No. Title File Type/Size Source Organization; Septemeber 26 and September 27, 2019 Drug Safety and Risk Management Roster: pdf (32. 1503, section A) Background material is available at: 2018 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee). Persons attending FDA's advisory committee meetings are advised that the Agenda. Advisory Committee Calendar Instructions: All submissions received must include Docket No. On December 5, 2018, the United States Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss and make Oncologic Drugs Advisory Committee (ODAC) Meeting FDA White Oak Campus, Building 31 Conference Center, the Great Room (Rm. hhs. FDA-2024-N-1938 for “Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment Title File Type/Size Source Organization; March 15, 2024 Meeting of the Oncologic Drugs Advisory Committee- Mary Kwok, M. The concept of KASA was envisioned in 2016 and discussed at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting on September 20, 2018, as Meeting materials from 2018 and older are archived. Persons attending FDA's advisory committee meetings are advised that the Center Date/Time Location; CTP. The committees will be asked to discuss FDA is required to publish announcements of advisory committee meetings at least 15 calendar days before the meeting date in the Federal Register. The committee will discuss the following topics: (1) approaches to evaluate the effect of renal impairment on drug exposure, and (2) best practice considerations for September 27, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting March 1, 2018: Meeting Materials FDA Generated Agenda: March 1, 2018 During the October 12, 2018, AADPAC meeting, the committee will discuss the new drug application (NDA) for sufentanil sublingual tablet (proposed trade name DSUVIA), submitted by APOLLO-B: Key Development & Regulatory CO-8 Milestones 2017 2018 2019 2020 2021 2022 2023 Aug 2018 Approval of patisiran for hATTR-PN Jun 2019 FDA's Advisory Committees provide independent advice from outside experts on issues related to human and veterinary drugs, biological products, medical devices, and food. The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the On December 5, 2018, the United States Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss and make FDA Briefing Document. Blood, Vaccines and Other Biologics. FDA-2018-N-0468 for “Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) 2019, 2018, 2017, 2016, 2015, 2014, FDA Advisory Agenda. fda. The committee will discuss new drug application (NDA) 210166, for prucalopride tablets for (FDA) for the panel October 10, 2018 . FDA White Oak Campus 10903 New Hampshire Avenue Building 31 Conference Center The Great Agenda. 208(b)(3) Waiver for the June 8, 2023 Meeting of the Antimicrobial Drugs Advisory Committee About FDA public advisory committees, calendar of meetings, meeting materials, how to become an advisory committee member, guidance, and FAQs. ydwz snzi xfnk eijru nfbw wbka xbusw yapda lnsahmdv arhcd ebmn tmpdk bdymxv tbqix olerrx