Namandje Bumpus, PhD Richard Pazdur, MD Office of External Affairs | FDA The site is secure. Before sharing sensitive information, make sure you're on a federal government site. In addition, the counselors advise agency officials on complex medical product approvals and safety issues and food safety and nutrition issues. March 2023 Office of Women's Health e-Update | FDA 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. Office of the Commissioner, Recalls, Market Withdrawals and Safety Alerts, Office of Minority Health and Health Equity, Office of Policy, Legislation, and International Affairs. Support staff assist with all OCC activities through applying their technical skills. Robert M. Califf, M.D. FDA Commissioner | FDA - U.S. Food and Drug Administration Effective March 31, 2019, FDA began operational implementation of an agency reorganization. Each committee is subject to renewal at two-year intervals unless the committee charter states otherwise. Office of the Chief Counsel | FDA Robert M. Califf M.D. 02/17/2022 - :. The .gov means its official.Federal government websites often end in .gov or .mil. Participate in Upcoming FDA Meetings. 1/19/2001, David A. Kessler, M.D. The commissioner is appointed by the president of the United States and must be confirmed by the Senate. Office of External Affairs, Recalls, Market Withdrawals and Safety Alerts, Office of Editorial and Creative Services. ODT Offices The Office of Digital Transformation (ODT) provides the vision and leadership in information technology (IT), data, and cybersecurity needed to advance FDA's mission and strategic. Erica Jefferson FDA | LinkedIn Director 3/15/1912, An official website of the United States government, : Food and Drug Administration. Office of the Commissioner (800) 741-8138 (301) 443-0572. 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. Director The .gov means its official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. FDA Archive; About FDA; Accessibility; Visitor Information; The site is secure. 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,. (DCI), Office of Clinical Policy and Programs Jeffrey Shuren, JD, MD Office of the Commissioner Regulatory Affairs Tobacco Toxicological Research: . (Acting), Reports directly to the Office of the Chief Scientist FDA is an agency within the Department of Health and Human Services. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19, March 22, 2023. (2012-Present) Office of the Commissioner | FDA - U.S. Food and Drug Administration The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. The site is secure. 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. 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. The commissioner has frequently been a physician, but this is not a requirement for the post. Vacant 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 . Significant vacancy announcements in the Office of the Commissioner will be highlighted on this page. 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. 12/12/1969, James L. Goddard, M.D. The FDAs reorganization has realigned several entities across the agency to promote strategic priorities, and will elevate the role of the centers, offices and field forces. Before sharing sensitive information, make sure you're on a federal government site. 6/30/1924 & ODT Offices | FDA - U.S. Food and Drug Administration Chief Scientist Contact FDA | FDA - U.S. Food and Drug Administration 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. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. Robert McKinnon Califf (born 1951) is an American cardiologist who currently serves as the 25th Commissioner of the Food and Drug Administration. 11/14/2002 - 02/24/2016 - 1/17/1999 - The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Deputy Commissioner for Policy, Planning, Legislation, and Analysis Leadership profiles, major initiatives, speeches, testimony and more, An official website of the United States government, : 5/31/1951, Walter G. Campbell The site is secure. 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. Robert Califf | FDA - U.S. Food and Drug Administration Director Committees are either mandated by statute or established at the discretion of the Department of Health and Human Services. In addition, the counselors have active roles in agency activities related to Congress. Janet Woodcock, MD, Chief Medical Officer 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. Chief Counsel 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). FDA Overview Organization Chart - Text Version | FDA The .gov means its official.Federal government websites often end in .gov or .mil. The .gov means its official.Federal government websites often end in .gov or .mil. 05/11/2017 - Previously, Dr. Califf served as Commissioner of Food and Drugs from February 2016 to January 2017. 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. 9/23/2005, Mark B. McClellan, M.D., Ph.D Before sharing sensitive information, make sure you're on a federal government site. 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. 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. Food and Drug Administration. 12/17/1989, Arthur H. Hayes, M.D. "They want leadership. 6/30/1979, Alexander M. Schmidt, M.D. Dr. Califf is a graduate of Duke University School of Medicine. Contact FDA's Office of Media Affairs. The site is secure. View text version of the above chart | Printer-friendly version (PDF - 96KB), Main Tel. (DCH), Office of Regulatory Affairs 7/20/1973 - The .gov means its official.Federal government websites often end in .gov or .mil. 7/15/1921, Harvey W. Wiley, M.D. U.S. Food and Drug Administration. 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. 04/05/2019, Robert M. Califf, M.D. Robert M. Califf, M.D., is Commissioner of Food and Drugs. 7/1/1968 - The site is secure. (DCM), Office of Operations FDA Leadership: 1907 to Today, Recalls, Market Withdrawals and Safety Alerts, Harvey W. Wiley: Pioneer Consumer Activist. 3/26/2004, Jane E. Henney, M.D. Unnumbered, colored rows indicate acting commissioners. Office of the Commissioner Organization Chart | FDA Robert M. Califf M.D. was named Commissioner of Food and Drugs on February 17, 2022. Judy McMeekin, PharmD The counselors also contribute significantly to the transparency of the agencys actions through interpretation and implementation of the Freedom of Information Act, the Federal Advisory Committee Act, the Administrative Procedure Act, and other administrative law activities. 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. 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. National Center for Toxicological Research Associate Commissioner Mark Raza, JD 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Director 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.. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Due to frequent controversies involving the FDA, appointments are not always prompt and the agency is often headed by an acting commissioner. OEA also serves as the focal point for speechwriting, creative and editorial services, and best practices in digital and web technology. FDA's FOI Points of Contact Find an FDA staff member Search the HHS employee directory (includes. FOOD AND DRUG ADMINISTRATION (FDA) Office of the Commissioner (OC) 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. 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. Virtual . Office of the Executive Secretariat Contact Number 1-888-INFO-FDA (1-888-463-6332) Back to . FDA's advisory committees are established to provide functions which support the agency's mission of protecting and promoting the public health, while meeting the requirements set forth in the Federal Advisory Committee Act. Commissioners | FDA - U.S. Food and Drug Administration (DCP), Reports directly to the Commissioner of Food and Drugs, Office of Womens Health Position title of the head of the organizational component. (DCB), Center for Devices and Radiological Health As Commissioner, Dr. Califf oversees the full breadth of the FDA portfolio and execution of the Federal. 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. 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. Commissioners rarely come from a food-related background.[1]. Randi Oster, MBA (Consumer Representative) Co-Founder and CEO, Help Me Health Fairfield, Connecticut 06824 Wael Sayej, MD Expertise: Pediatric Gastroenterology The site is secure. (DCO), Office of the Chief Scientist Principal Deputy Commissioner Food and Drug Administration White Oak Campus . Silver Spring, MD 20993 The commissioner is appointed by the president of the United States and must be confirmed by the Senate. (DCE), Center for Tobacco Products (DCG), Oncology Center of Excellence 5/6/1944 - Commissioner of Food and Drugs - Wikipedia Advisory Committees | FDA - U.S. Food and Drug Administration was named Commissioner of Food and Drugs on February 17, 2022. Department of Health and Human Services Freedom of Information Act (FOIA) Call 301-796-3900. For Government; For Press; Combination Products; Advisory Committees; 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. Frank Yiannas The FDA uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. Ensures consistent visual identity and messaging across the Agency. 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. 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 site is secure. 4/13/1981 - Biden in no rush to pick new FDA chief | CNN FOOD AND DRUG ADMINISTRATION (FDA) Office of the Commissioner (OC) Meeting of the Pediatric Advisory Committee (PAC) September 15, 2020 MEETING ROSTER (cont.) (DCAD), Center for Biologics Evaluation and Research The .gov means its official.Federal government websites often end in .gov or .mil. 01/20/2017, Margaret Hamburg, M.D. 2/28/1997, Frank E. Young, MD, Ph.D. Provides communication expertise and state-of-the-art digital guidance and tools for application across the Agency. 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. 7/18/2005 - Associate Commissioner 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. 12/13/2006 - Director Public Meeting: Good Manufacturing Practices for Cosmetic . Coordinates and implements policies, programs and initiatives related to MedWatch, including MedWatch website and e-list. Scientific Publications by FDA Staff - accessdata.fda.gov 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. An official website of the United States government, : Brian King, PhD, MPH This organization chart reflects the new structure. FDA Organization Charts, Recalls, Market Withdrawals and Safety Alerts, FDA Overview Organization Chart - Text Version. 4/30/1944, Carl L. Alsberg, M.D. 10/21/1979 - Each organizational component will be depicted in the following standard format: Office of the Commissioner 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 . The site is secure. Martina Varnado, MPA Serves as the central point of communication and education about the FDAs public health and regulatory activity. Joseph Petrosino (born Giuseppe Petrosino, Italian: [duzppe petrozino; -sino]; August 30, 1860 - March 12, 1909) was an Italian-born New York City Police Department (NYPD) officer who was a pioneer in the fight against organized crime.Crime fighting techniques that Petrosino pioneered are still practiced by law enforcement agencies. 10903 New Hampshire Ave Leads efforts to enhance FDA's communications infrastructure to better serve the public. 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. (DCQ), An official website of the United States government, : Counselor to the Commissioner Before sharing sensitive information, make sure you're on a federal government site. Commissioner of Food and Drugs 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. Before sharing sensitive information, make sure you're on a federal government site. Director Thinh Nguyen 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. 12/13/1969 - The site is secure. 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. 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. 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. Coordinates Agency-wide communication activities. Webinar Series to Discuss Infant Formula Food Ingredients and Packaging Requirements, May 24, 2023. Footer Links. (DCAB), Office of the Counselor to the Commissioner 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. The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of. Office of the Commissioner Effective March 31, 2019, FDA began operational implementation of an agency reorganization. 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. 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. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Chief Information Officer The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Andi Fristedt, MPA He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. 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. Hours Available. Director 12/16/1912 - The counselors help FDA implement new, as well as longstanding, legislation, which often involves complex legal analyses of intricate statutory provisions. Director Hilary Marston, MD, MPH (DCJ), Office of External Affairs Acting Commissioners | FDA - U.S. Food and Drug Administration Susan Mayne, PhD Jobs and Training at FDA, Recalls, Market Withdrawals and Safety Alerts, FDA's Anti-Harassment and Inappropriate Conduct Policy, Jobs at the Center for Devices and Radiological Health (CDRH), Jobs at the Center for Drug Evaluation and Research (CDER), Scientific Internships, Fellowships / Trainees and Non-U.S. Citizens, Attorney Career Opportunities (Multiple Vacancies), Position Open: Associate Director for Scientific Staffing, View all current FDA job openings at USAJobs. Deputy Commissioner for Operations and Chief Operating Officer FDA's reorganization reflects the agency's commitment to modernizing its. Director An official website of the United States government, : The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 7/1/1927 - Kaveeta Vasisht, MD, PharmD Tracey Forfa, JD Before sharing sensitive information, make sure you're on a federal government site. Deputy Commissioners | FDA - U.S. Food and Drug Administration Through all of these activities, OCC advances FDAs mission of promoting and protecting the public health. 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. For example, the counselors review agency officials written congressional testimony and congressional correspondence, analyze pending FDA-related legislation, and help FDA respond to congressional requests for technical assistance or other briefings. Present, Stephen M. Hahn, M.D. 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. Robert Califf - Wikipedia Being in limbo is . (DCA), Reports directly to the General Counsel of HHS Robert M. Califf, MD, Reports directly to the Commissioner of Food and Drugs