Edit Organization: Antimicrobial Drugs Advisory Committee

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'''Antimicrobial Drugs Advisory Committee (AMDAC)''' is an advisory body within the Food and Drug Administration (FDA), originally established as the Anti-Infective Drugs Advisory Committee before its current name was adopted, tasked with evaluating the safety and effectiveness of human drug products for infectious diseases. Comprising 13 core voting members with expertise in fields like infectious disease, microbiology, and epidemiology, AMDAC meets 2-4 times annually to provide non-binding recommendations to the FDA Commissioner, influencing decisions on drug approvals and policies. {{Official URL (simple)|url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee}} ==Mission== The Antimicrobial Drugs Advisory Committee seeks to ensure the availability of safe and effective antimicrobial drugs by reviewing scientific data on marketed and investigational products, offering expert advice to the FDA. Its mission supports the agency’s broader goal of protecting public health by providing independent assessments on drug applications and emerging infectious disease challenges.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=Antimicrobial Drugs Advisory Committee |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Parent organization== The Antimicrobial Drugs Advisory Committee operates under the [[Food and Drug Administration]], which manages its activities within the Center for Drug Evaluation and Research (CDER). Its top organization is the [[Department of Health and Human Services]], overseeing FDA operations and public health policy.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/about-advisory-committees |title=About Advisory Committees |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Legislation== The AMDAC was not created by specific legislation but is authorized under the FDA’s general authority (15 U.S.C. 1451 et seq.; 21 U.S.C. 321 et seq.) and governed by the [https://www.govinfo.gov/content/pkg/USCODE-2022-title5/pdf/USCODE-2022-title5-app-federal.pdf Federal Advisory Committee Act of 1972], which mandates advisory bodies to support federal decision-making. Its charter is renewed biennially, with the latest filing on October 7, 2024.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/charter-antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=AMDAC Charter |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Partners== The AMDAC collaborates with: * [[Center for Drug Evaluation and Research]] for operational support * Industry representatives as non-voting members * Consumer advocacy groups for diverse input<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/roster-antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=AMDAC Roster |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Number of employees== The AMDAC consists of 13 core voting members, including the Chairperson, selected for their expertise; no full-time staff are directly employed, as support is provided by FDA personnel.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/charter-antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=AMDAC Charter |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Organization structure== The AMDAC is a flat advisory body with no formal sub-organizations: * Core Voting Members review drug data and provide recommendations. * Temporary Consultants augment expertise as needed for specific meetings. ===Leader=== The Antimicrobial Drugs Advisory Committee is headed by a Chairperson, appointed by the FDA Commissioner or designee.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/roster-antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=AMDAC Roster |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ===Divisions=== The AMDAC has no permanent divisions but organizes ad hoc: * Meeting Panels convene 2-4 times yearly to address specific drug evaluations.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=Antimicrobial Drugs Advisory Committee |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==List of programs== The AMDAC does not run standalone programs but supports: * Drug Review Meetings - https://www.fda.gov/advisory-committees/committees-and-meeting-materials/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee<ref>{{cite web |url=https://www.fda.gov/advisory-committees/committees-and-meeting-materials/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=AMDAC Meeting Materials |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Last total enacted budget== The AMDAC’s estimated annual operating cost for FY 2025 is $336,686, including $128,055 for member compensation and travel and $208,631 for 1.1 person-years of FDA staff support.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/charter-antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=AMDAC Charter |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Staff== The AMDAC’s 13 voting members are not employees but appointed experts serving up to four-year terms; a Designated Federal Officer (DFO) and additional FDA staff (1.1 person-years) provide support.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/roster-antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=AMDAC Roster |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Funding== The AMDAC is funded through the FDA budget, under the Department of Health and Human Services, covering member compensation, travel, and staff support, with no independent revenue sources.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/charter-antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=AMDAC Charter |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Services provided== The AMDAC provides expert evaluations of antimicrobial drug safety and efficacy, hosts public meetings to discuss drug applications, and offers consultation on infectious disease policy, aiding FDA decision-making.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=Antimicrobial Drugs Advisory Committee |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Regulations overseen== The AMDAC does not oversee regulations but advises on drug approvals under FDA jurisdiction, such as 21 CFR Part 14, which governs advisory committees.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/charter-antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=AMDAC Charter |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==Headquarters address== The headquarters address, as listed on Google Maps, is 10903 New Hampshire Ave, Silver Spring, MD 20993, USA, within the FDA White Oak Campus. ==History== Originally named the Anti-Infective Drugs Advisory Committee, the AMDAC was established under FDA authority following the Federal Advisory Committee Act of 1972, evolving to its current name to reflect a broader focus on antimicrobial drugs. Its charter has been renewed biennially, with significant meetings addressing drugs like molnupiravir (2021) and sulopenem (2024), shaping infectious disease treatment policy.<ref>{{cite web |url=https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee |title=Antimicrobial Drugs Advisory Committee |publisher=Food and Drug Administration |access-date=February 22, 2025}}</ref> ==External links== * [https://www.fda.gov/advisoryMIDDLE-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee Official Website] * [[wikipedia:Antimicrobial_Drugs_Advisory_Committee]] * [https://www.fda.gov/advisory-committees/committees-and-meeting-materials/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee AMDAC Meeting Materials] ==References== <references />