fda office of the commissioner
Kaveeta Vasisht, MD, PharmD Read full bio, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts. Significant vacancy announcements in the Office of the Commissioner will be highlighted on this page. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. FDA Principal Deputy Commissioner Janet Woodcock and health scholars discuss COVID-19's impact on health policy at an event hosted by the American Enterprise Institute (AEI) in Washington, DC. Prior to rejoining the FDA, Dr. Califf was head of medical strategy and Senior Advisor at Alphabet Inc., contributing to strategy and policy for its health subsidiaries Verily Life Sciences and Google Health. In addition, the counselors have active roles in agency activities related to Congress. He also served as the principal investigator for Duke's Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory Coordinating Center. The Standard Administrative code (Alphanumeric sequence of characters beginning with the letter D) is represented in alphabetical order within the hierarchy of their office component from top to bottom and left to right. The site is secure. The .gov means its official.Federal government websites often end in .gov or .mil. (DCP), Reports directly to the Commissioner of Food and Drugs, Office of Womens Health President Joe Biden nominated Dr. Califf to head the U.S. Food and Drug Administration and Dr. Califf was sworn in on February 17, 2022. 10903 New Hampshire Ave Silver Spring, MD 20993 United States. Committees are either mandated by statute or established at the discretion of the Department of Health and Human Services. Before sharing sensitive information, make sure you're on a federal government site. The .gov means its official.Federal government websites often end in .gov or .mil. Brian King, PhD, MPH Campbell had previously served as Commissioner, Califf had previously served as Commissioner, Last edited on 15 December 2022, at 00:43, United States Department of Health and Human Services, "How the FDA's food division fails to regulate health and safety hazards", "Meet Stephen Ostroff, Deputy Commissioner for Foods and Veterinary Medicine", "Trump announces plan to nominate Texas cancer doctor to run FDA", "Janet Woodcock, MD, Appointed as Acting FDA Commissioner", https://en.wikipedia.org/w/index.php?title=Commissioner_of_Food_and_Drugs&oldid=1127488556, This page was last edited on 15 December 2022, at 00:43. Such services include, for example, review and revision of draft and final regulations, draft and final guidance documents, responses to citizen petitions, draft legislation, press materials, and correspondence. Richard Pazdur, MD 4/13/1981 - Office of External Affairs | FDA Virtual . Chief Counsel Before sharing sensitive information, make sure you're on a federal government site. The .gov means its official.Federal government websites often end in .gov or .mil. Commissioners | FDA - U.S. Food and Drug Administration Joseph Petrosino - Wikipedia Page 2 of 5 . Advises the Commissioner, Deputy Commissioners and other key agency officials on FDA's communications to the media, Congress, and the general public on issues that affect agency-wide programs,. Frank Yiannas Erica Jefferson Commissioner of Food and Drugs - Wikipedia Director 12/17/1989, Arthur H. Hayes, M.D. Participate in Upcoming FDA Meetings. 4/30/1944, Carl L. Alsberg, M.D. The Office of the Commissioner (OC) provides centralized agency-wide program direction and management services for agency programs to ensure that FDA's consumer protection efforts are effectively managed within its regulatory framework and those available resources are put to the most efficient use. Advisory Committees | FDA - U.S. Food and Drug Administration The .gov means its official.Federal government websites often end in .gov or .mil. The United States Commissioner of Food and Drugs is the head of the Food and Drug Administration (FDA), an agency of the United States Department of Health and Human Services. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,300 publications in the peer-reviewed literature. Coordinates and implements policies, programs and initiatives related to MedWatch, including MedWatch website and e-list. Robert M. Califf, M.D. Director The .gov means its official.Federal government websites often end in .gov or .mil. 12/17/2019 - 01/20/2021, Scott Gottlieb, M.D. For Government; For Press; Combination Products; Advisory Committees; FDAs reorganization reflects the agencys commitment to modernizing its structure to advance its mission to protect and promote public health, and to meet the challenges of rapid innovation across the industries regulated by FDA. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Commissioner of Food and Drugs - Food and Drug Administration, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health, Center for Drug Evaluation and Research | CDER, Center for Food Safety and Applied Nutrition (CFSAN). The litigators and counselors also advise agency enforcement officials on pending compliance issues and review certain warning letters sent to firms and individuals believed to have violated the FDCA or related laws. United States, Advisory Committee Oversight and Management Staff, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Recently Updated Advisory Committee Materials, August 22-23, 2023: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, September 6, 2023: Patient Engagement Advisory Committee Meeting Announcement, September 11-12, 2023: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement, September 13, 2023: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement, Science Board to the Food and Drug Administration, Applying for Membership on FDA Advisory Committees, Advisory Committee Vacancies, Qualifications, and Experience, Advisory Committee Laws, Regulations, and Guidance, Consumer Representatives on FDA Advisory Committees, Public Meetings at the FDA White Oak Campus. The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of. Dr. Califf has also served on the Board of Scientific Counselors for the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging. Office of the Chief Counsel | FDA Office of the Commissioner Organization Chart | FDA Follow FDA on LinkedIn View FDA videos on YouTube Subscribe to FDA RSS feeds. Dr. Califf is a graduate of Duke University School of Medicine. The site is secure. The commissioner has frequently been a physician, but this is not a requirement for the post. (DCG), Oncology Center of Excellence Thinh Nguyen 6/30/1979, Alexander M. Schmidt, M.D. Public Health Service rank if any, first name, middle initial if any, last name, post graduate degrees if any, and if the individual is designated as acting. Food and Drug Administration White Oak Campus . Judy McMeekin, PharmD Serves as the central point of communication and education about the FDAs public health and regulatory activity. Tracey Forfa, JD The commissioner is appointed by the president of the United States and must be confirmed by the Senate. Principal Deputy Commissioner Before sharing sensitive information, make sure you're on a federal government site. Before sharing sensitive information, make sure you're on a federal government site. The .gov means its official.Federal government websites often end in .gov or .mil. (DCD), Center for Food Safety and Applied Nutrition He was first nominated to be commissioner in September 2015 by President Barack Obama [1] and he was confirmed by the U.S. Senate in February 2016, [2] serving until January 20, 2017. The OC also provides policy making, program direction, coordination and liaison, and expert advice to agency leadership and programs in support of FDA's science-based work. 02/17/2022 - Unnumbered, colored rows indicate acting commissioners. This organization chart reflects the new structure. 5/6/1944 - The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The following header reflects the organizational hierarchy. 1/20/2009, Lester M. Crawford, D.V.M., Ph.D. 9/23/2005, Mark B. McClellan, M.D., Ph.D was named Commissioner of Food and Drugs on February 17, 2022. 1/19/2001, David A. Kessler, M.D. Commissioners rarely come from a food-related background.[1]. Martina Varnado, MPA Serves as a Liaison between FDA and health professional and patient advocacy organizations to solve problems and address concerns these groups have with agency policies and programs related to human and medical product development and safety. (DCB), Center for Devices and Radiological Health ODT Offices | FDA - U.S. Food and Drug Administration Associate Commissioner The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Before sharing sensitive information, make sure you're on a federal government site. Jeffrey Shuren, JD, MD Associate Commissioner Director Dr. Califf served as the FDAs Deputy Commissioner for Medical Products and Tobacco from February 2015 until his first appointment as Commissioner in February 2016. View text version of the above chart | Printer-friendly version (PDF - 96KB), Main Tel. Namandje Bumpus, PhD Director 1/1/1907 - Robert M. Califf, M.D., is Commissioner of Food and Drugs. Present, Stephen M. Hahn, M.D. 01/20/2017, Margaret Hamburg, M.D. The .gov means its official.Federal government websites often end in .gov or .mil. Andi Fristedt, MPA 5/31/1951, Walter G. Campbell (DCE), Center for Tobacco Products The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. While at Duke, Dr. Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. 7/15/1984 - FDA's reorganization reflects the agency's commitment to modernizing its. Dr. Califf became a Member of the National Academy of Medicine (formerly known as the Institute of Medicine (IOM)) in 2016, one of the highest honors in the fields of health and medicine. Footer Links. (DCQ), An official website of the United States government, : Office of the Commissioner Organization Chart | FDA Office of the Commissioner Organization Chart View text version of the above chart | Printer-friendly version (PDF - 96KB) Main Tel. He joined Alphabet in 2019, after serving as a professor of medicine and vice chancellor for clinical and translational research at Duke University. UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting, March 22, 2023. Public Meeting: Good Manufacturing Practices for Cosmetic . The OCC litigators and counselors also have central roles in FDAs administrative proceedings, such as clinical investigator disqualification hearings, hearings on product approval withdrawals, and civil money penalty hearings. 12/16/1912 - The litigators frequently work closely with senior officials at the Department of Justice and play an active role in all of FDA's cases, including matters before the United States District Courts, the Courts of Appeal, and the United States Supreme Court. Robert McKinnon Califf (born 1951) is an American cardiologist who currently serves as the 25th Commissioner of the Food and Drug Administration. : 301-796-5000 | Fax: 301-847-3531 | White Oak Building 1, Room 2217, 10903 New Hampshire Ave., Silver Spring, MD 20993, Approved by FDA Reorganization Coordinator and Principal Delegation Control Officer, Return to Office of the Commissioner Organization Charts, An official website of the United States government, : 3/15/1912, An official website of the United States government, : Amid A Pandemic, The FDA Doesn't Have A Permanent Leader : Shots - NPR Before sharing sensitive information, make sure you're on a federal government site. Office of the Commissioner, Recalls, Market Withdrawals and Safety Alerts, Office of Minority Health and Health Equity, Office of Policy, Legislation, and International Affairs. The FDA uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. The .gov means its official.Federal government websites often end in .gov or .mil. Advises the Commissioner, Deputy Commissioners and other senior staff throughout FDA on sensitive and controversial programs and initiatives that affect external stakeholder groups; provides historical expertise and records to inform those decisions. (DCAA), Reports directly to the Commissioner of Food and Drugs The counselors help FDA implement new, as well as longstanding, legislation, which often involves complex legal analyses of intricate statutory provisions. 1/17/1966 - Each committee is subject to renewal at two-year intervals unless the committee charter states otherwise. Leads efforts to enhance FDA's communications infrastructure to better serve the public. (DCN), Office of Policy, Legislation, International Affairs Office of the Chief Counsel, Recalls, Market Withdrawals and Safety Alerts, Hiring Opportunities in the Office of Chief Counsel, Current Attorney Career Opportunities (Multiple Vacancies), Office of Chief Counsel, Food and Drug Administration, Service of Legal Documents on the Food and Drug Administration, CFR - Code of Federal Regulations Title 21, Milestones in U.S. Food and Drug Law History. 05/11/2017 - 6/30/1924 & Ensures consistent visual identity and messaging across the Agency. National Center for Toxicological Research Director The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Director Director Director Before sharing sensitive information, make sure you're on a federal government site. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. (DCI), Office of Clinical Policy and Programs 10903 New Hampshire Ave He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke. 4/4/1977 - As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. Robert M. Califf, MD, Reports directly to the Commissioner of Food and Drugs The counselors also advise FDA officials on their interactions with stakeholders, such as members of the public, health care providers and institutions, regulated firms, and associations representing a broad range of interest groups. Vidyut Desai Jobs in the Office of the Commissioner | FDA Acting Commissioners FDA Leadership: 1907 to Today Acting Commissioners This page chronicles individuals who were asked to lead the agency in the absence of a Senate-confirmed commissioner.. Deputy Commissioner Due to frequent controversies involving the FDA, appointments are not always prompt and the agency is often headed by an acting commissioner. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Previously, Dr. Califf served as Commissioner of Food and Drugs from February 2016 to January 2017. The commissioner reports to the Secretary of Health and Human Services. Deputy Commissioner for Policy, Planning, Legislation, and Analysis U.S. Food and Drug Administration. In addition, the counselors advise agency officials on complex medical product approvals and safety issues and food safety and nutrition issues. Support staff assist with all OCC activities through applying their technical skills. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. Deputy Commissioners | FDA - U.S. Food and Drug Administration (DCK), Office of Food Policy and Response Office of the Commissioner Effective March 31, 2019, FDA began operational implementation of an agency reorganization. FDA Archive; About FDA; Accessibility; Visitor Information; Being in limbo is . 3/15/1973, Herbert L. Ley, Jr., M.D. (Acting) FDA Organization Charts, Recalls, Market Withdrawals and Safety Alerts, Office of the Commissioner Organization Chart. 7/1/1927 - The site is secure. Robert M. Califf M.D. 04/05/2019, Robert M. Califf, M.D. 12/12/1969, James L. Goddard, M.D. (DCAD), Center for Biologics Evaluation and Research The Office of the Commissioner (OC) provides centralized agency-wide program direction and management services for agency programs to ensure that FDA's consumer protection efforts are effectively . An official website of the United States government, : The .gov means its official.Federal government websites often end in .gov or .mil. 10/21/1979 - Office of the Commissioner | FDA - U.S. Food and Drug Administration 11/8/1990 - May 2023 Office of Women's Health e-Update | FDA President Joe Biden nominated Dr. Califf to head the U.S. Food and Drug Administration and Dr. Califf was sworn in on February 17, 2022. Robert Califf - Wikipedia Director Commissioner of Food and Drugs FOOD AND DRUG ADMINISTRATION (FDA) Office of the Commissioner (OC) Meeting of the Pediatric Advisory Committee (PAC) September 15, 2020 MEETING ROSTER (cont.) An official website of the United States government, : Janet Woodcock, MD, Chief Medical Officer Webinar Series to Discuss Infant Formula Food Ingredients and Packaging Requirements, May 24, 2023. (DCA), Reports directly to the General Counsel of HHS Randi Oster, MBA (Consumer Representative) Co-Founder and CEO, Help Me Health Fairfield, Connecticut 06824 Wael Sayej, MD Expertise: Pediatric Gastroenterology Mark Raza, JD As Commissioner, Dr. Califfoversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. 7/18/2005 - James Sigg Freedom of Information Act (FOIA) Call 301-796-3900. 11/30/1976, Charles C. Edwards, M.D. The counselors also participate in FDAs interactions with other federal agencies (e.g., USDA, EPA, FTC) and with state public health agencies. Office of the Commissioner Regulatory Affairs Tobacco Toxicological Research: . Advises the Commissioner, Deputy Commissioners and other key agency officials on FDAs communications to the media, Congress, and the general public on issues that affect agency-wide programs, projects, strategies, partnerships and initiatives. Robert Califf | FDA - U.S. Food and Drug Administration 04/04/2015, Andrew C. von Eschenbach, M.D. The following is the Food and Drug Administration organizational structure depicting the organizational structures reporting to the Commissioner of Food and Drugs within the Office of the Commissioner. Before sharing sensitive information, make sure you're on a federal government site. 02/24/2016 - FDA Homepage. This includes the development, coordination, and leadership of all FDA communications and outreach efforts to the news media, health professionals, patient advocates, industry, states, consumer groups, and the general public. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. FDA's FOI Points of Contact Find an FDA staff member Search the HHS employee directory (includes. Department of Health and Human Services FDA Organization Charts, Recalls, Market Withdrawals and Safety Alerts, FDA Overview Organization Chart - Text Version. FOOD AND DRUG ADMINISTRATION (FDA) Office of the Commissioner (OC) Last month, six former FDA commissioners urged Biden to select someone soon, in part to boost agency morale after it was battered by his predecessor. 7/20/1973 - During emergencies, such as foodborne illness outbreaks, novel influenza epidemics, or potential bioterrorism attacks, the counselors provide legal services essential to the governments effective immediate response. Previously, Dr. Califf served as Commissioner of Food. For example, Andrew von Eschenbach's appointment was held up by senators who objected to the FDA's refusal to allow emergency contraception to be sold over the counter. 1/17/1999 - Leadership profiles, major initiatives, speeches, testimony and more, An official website of the United States government, : The litigators work closely with agency compliance personnel to ensure an adequate evidentiary foundation for enforcement matters, prepare referrals to the Department of Justice, draft memoranda setting out the agency's interpretation of the law, develop case strategy, conduct negotiations, prepare and respond to discovery, and are key participants in hearings, trials, and appellate proceedings. (DCAC), Office of Digital Transformation Litigators handle both civil and criminal enforcement cases, and defend challenges to provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), the implementing regulations, and FDA policies, initiatives, and decisions. The counselors provide legal services to FDA and HHS officials on matters involving FDA-regulated products, such as drugs, biologics, food, medical devices, cosmetics, veterinary products, radiation-emitting products, and tobacco products. 1/20/1981, Donald Kennedy, Ph.D. Tucker Patterson, PhD (DCAB), Office of the Counselor to the Commissioner (DCH), Office of Regulatory Affairs Position title of the head of the organizational component. Participate in Upcoming FDA Meetings. Associate Commissioner Director The site is secure. Before sharing sensitive information, make sure you're on a federal government site. FDA Overview Organization Chart - Text Version | FDA Deputy Commissioner for Operations and Chief Operating Officer (COO) Curtis L. Coy (2011-2011) Acting Deputy Commissioner, Office for Administration and Chief Financial Officer (CFO) Caroline Lewis (2011-2011) Acting Deputy Commissioner, Office for Administration and Chief Financial Officer (CFO) Walter Harris, M.B.A., P.M.P. Associate Commissioner Patrizia Cavazzoni, MD The site is secure. FDA is an agency within the Department of Health and Human Services. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products. Chief Scientist Office of the Commissioner (800) 741-8138 (301) 443-0572. 12/13/2006 - (Acting), Reports directly to the Office of the Chief Scientist The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The site is secure. Chief Information Officer Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19, March 22, 2023. FDA commissioner is a "particularly rough job in wartime," said Steven Grossman, executive director of the Alliance for a Stronger FDA, an outside organization consisting of industry, research and . (DCF), Center for Veterinary Medicine Food and Drug Administration. Dr. Califf has served on numerous IOM committees, and he has served as a member of the FDA Cardiorenal Advisory Panel and the FDA Science Board's Subcommittee on Science and Technology. Scientific Publications by FDA Staff - accessdata.fda.gov OEA also serves as the focal point for speechwriting, creative and editorial services, and best practices in digital and web technology. Effective March 31, 2019, FDA began operational implementation of an agency reorganization. was named Commissioner of Food and Drugs on February 17, 2022. (DCO), Office of the Chief Scientist Vacant 3/26/2004, Jane E. Henney, M.D. 05/22/2009 - Through all of these activities, OCC advances FDAs mission of promoting and protecting the public health. The site is secure. Peter Marks, MD, PhD :. (DCM), Office of Operations The litigators act as the liaison to the Department of Justice during active litigation, and in many criminal prosecutions have been asked to work as Special Assistant United States Attorneys, assuming primary responsibility for prosecuting violations of the FDCA or related statutes. Contact FDA's Office of Media Affairs. Janet Woodcock, MD Chief of Staff Julia Tierney, JD (DCA) Chief Medical Officer Hilary Marston, MD, MPH (DCA) Reports directly to the General Counsel of HHS Office of the Chief Counsel Chief. FDA Leadership: 1907 to Today, Recalls, Market Withdrawals and Safety Alerts, Harvey W. Wiley: Pioneer Consumer Activist. "They want leadership. (2012-Present) Hilary Marston, MD, MPH FDA | LinkedIn The site is secure.
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