The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Frank Edward Young was an American physician who served as Commissioner of Food and Drugs from 1984 to 1989 and later as a deputy assistant secretary in the United States Department of Health and Human Services. In 2013 he joined Braeburn Pharmaceuticals as executive vice president, clinical and regulatory affairs. In 2018, he became the executive vice president of clinical and regulatory affairs at TissueTech Inc.
Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. It is administered by subcutaneous injection. It works by inactivating tumor necrosis factor-alpha (TNFα).
Rivaroxaban, sold under the brand name Xarelto among others, is an anticoagulant medication used to treat and prevent blood clots. Specifically it is used to treat deep vein thrombosis and pulmonary emboli and prevent blood clots in atrial fibrillation and following hip or knee surgery. It is taken by mouth.
Herbert Leonard Ley Jr. was an American physician and the 9th Commissioner and head of the U.S. Food and Drug Administration (FDA).
A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.
The Florida Department of Health is responsible for protecting the public health and safety of the residents and visitors of the state of Florida. It is a cabinet-level agency of the state government, headed by a state surgeon general who reports to the governor. The department has its headquarters in Tallahassee.
Stephen Michael Hahn is an American physician who served as the commissioner of food and drugs from 2019 to 2021. Before becoming commissioner, he was an oncologist serving as chief medical executive of the MD Anderson Cancer Center. In 2021, he became chief medical officer at Flagship Pioneering, the venture capital firm that launched Moderna.
Margaret Ann "Peggy" Hamburg is an American physician and public health administrator, who is serving as the chair of the board of the American Association for the Advancement of Science (AAAS) and co-chair of the InterAcademy Partnership (IAP). She served as the 21st Commissioner of the U.S. Food and Drug Administration from May 2009 to April 2015.
The Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA), is the public health regulatory agency responsible for ensuring that United States' commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. The FSIS draws its authority from the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957 and the Egg Products Inspection Act of 1970.
Brett P. Giroir is an American pediatrician. He was formerly the U.S. assistant secretary for health, a four-star admiral in the U.S. Public Health Service Commissioned Corps and an acting Food and Drug Administration commissioner.
Eteplirsen is a medication to treat, but not cure, some types of Duchenne muscular dystrophy (DMD), caused by a specific mutation. Eteplirsen only targets specific mutations and can be used to treat about 14% of DMD cases. Eteplirsen is a form of antisense therapy.
Luciana Borio is a Brazilian-American infectious disease physician and public health administrator. She is a vice president at In-Q-Tel. She previously served as director for Medical and Biodefense Preparedness at the National Security Council, acting chief scientist of the U.S. Food and Drug Administration (FDA), assistant commissioner for counterterrorism policy of the FDA, and director of FDA's Office of Counterterrorism and Emerging Threats. She is known for her work advancing clinical trials, the development of medical countermeasures for health emergencies, and the public health responses to Ebola and Zika outbreaks.
Robert McKinnon Califf is an American cardiologist who served as the 25th commissioner of food and drugs from 2016 to 2017 and again from 2022 to 2025.
Stephen Ostroff is an American physician. He served as acting commissioner of the U.S. Food and Drug Administration from April 1, 2015, to February 21, 2016, and from January to May 2017.
Burosumab, sold under the brand name Crysvita, is a human monoclonal antibody medication approved 2018 for the treatment of X-linked hypophosphatemia and tumor-induced osteomalacia.
Scott Gottlieb is an American physician, investor, and author who served as the 23rd commissioner of the Food and Drug Administration (FDA) from May 2017 until April 2019. He is presently a senior fellow at the conservative think tank the American Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA), a member of the board of directors of drug maker Pfizer, Inc and gene sequencing company Illumina, Inc. and a contributor to cable financial news network CNBC and the CBS News program Face the Nation. An elected member of the National Academy of Medicine, Gottlieb is the author of The New York Times best selling book Uncontrolled Spread on the COVID-19 pandemic and the national security vulnerabilities that it revealed. His forthcoming book, The Miracle Century: Making Sense of the Cell Therapy Revolution, traces the scientific achievements that propelled progress in cell therapies.
Janet Woodcock is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA). She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.
Patrizia Cavazzoni is the director of the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). Prior to this position she worked at Pfizer and had been a psychiatrist. She resigned from FDA on January 10, 2025, ten days before Donald Trump took office.
