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.
The United States secretary of health and human services is the head of the United States Department of Health and Human Services, and serves as the principal advisor to the president of the United States on all health matters. The secretary is a member of the United States Cabinet. The office was formerly Secretary of Health, Education, and Welfare. In 1980, the Department of Health, Education, and Welfare was renamed the Department of Health and Human Services, and its education functions and Rehabilitation Services Administration were transferred to the new United States Department of Education. Patricia Roberts Harris headed the department before and after it was renamed.
Adalimumab, sold under the brand name Humira, among others, is a monoclonal antibody used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis. It is administered by injection under the skin.
Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the production of white blood cells (neutrophils). Pegfilgrastim was developed by Amgen.
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.
The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pets or companion animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.
Herbert Leonard Ley Jr. was an American physician and the 10th 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.
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.
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.
Tecovirimat, sold under the brand name Tpoxx among others, is an antiviral medication with activity against orthopoxviruses such as smallpox and monkeypox. It is the first antipoxviral drug approved in the United States. It is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein.
Apixaban, sold under the brand name Eliquis, is an anticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation through directly inhibiting factor Xa. Specifically it is used to prevent blood clots following hip or knee replacement and in those with a history of prior clots. It is used as an alternative to warfarin and does not require monitoring by blood tests or dietary restrictions. It is taken by mouth.
Brett P. Giroir is an American pediatrician and a former four-star admiral in the U.S. Public Health Service Commissioned Corps. Dr. Giroir currently serves as CEO and a member of the Board of Directors for Altesa BioSciences, Inc, a clinical stage biopharmaceutical company focusing on developing new treatments for respiratory viruses and global viral threats. He is also a co-founder and independent director for Revelar Biotherapeutics, and an independent director for OncoNano Medicine. His non-profit activities include Board service on the Global Virus Network and Remote Area Medical (RAM), and he remains active in global humanitarian initiatives in Latin America and Sub-Saharan Africa. He previously served as the 16th assistant secretary for health during the Trump administration from February 15, 2018, to January 19, 2021. He concurrently served as the secretary's principal public health and science adviser, the senior adviser for the Health Resources and Services Administration, the Centers for Disease Control and Prevention, and the Substance Abuse and Mental Health Services Administration as well as the senior adviser to the secretary for Opioid Policy. From 2020 to 2021, he served additionally as the director of the U.S. coronavirus diagnostic testing, and as the U.S. representative on the World Health Organization Executive Board. As COVID-19 testing czar, he was part of the White House Coronavirus Task Force.
Robert McKinnon Califf is an American cardiologist who currently serves as the 25th Commissioner of the Food and Drug Administration.
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.
Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate used for the treatment of urothelial cancer. It is a nectin-4-directed antibody and microtubule inhibitor conjugate. Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker.
Scott Gottlieb is an American physician and investor 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, a member of the board of directors of Illumina, Inc., a contributor to the cable financial news network CNBC, and a frequent guest on 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.
Janet Woodcock is an American physician and former 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.
Cabotegravir/rilpivirine, sold under the brand name Cabenuva, is a co-packaged antiretroviral medication for the treatment of HIV/AIDS. It contains cabotegravir and rilpivirine in a package with two separate injection vials.
