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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.
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional,as opposed to prescription drugs,which may be supplied only to consumers possessing a valid prescription. In many countries,OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations,governments allow manufacturers the freedom to formulate ingredients,or combinations of ingredients,into proprietary mixtures.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same,the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original,but it may differ in some characteristics such as the manufacturing process,formulation,excipients,color,taste,and packaging.
The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical,if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk.
Etanercept,sold under the brand name Enbrel among others,is a biologic medical product that is used to treat autoimmune diseases by interfering with tumor necrosis factor (TNF),a soluble inflammatory cytokine,by acting as a TNF inhibitor. It has US Food and Drug Administration (FDA) approval to treat rheumatoid arthritis,juvenile idiopathic arthritis and psoriatic arthritis,plaque psoriasis and ankylosing spondylitis. Tumor necrosis factor alpha (TNFα) is the "master regulator" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha.
Cefuroxime,sold under the brand name Zinacef among others,is a second-generation cephalosporin antibiotic used to treat and prevent a number of bacterial infections. These include pneumonia,meningitis,otitis media,sepsis,urinary tract infections,and Lyme disease. It is used by mouth or by injection into a vein or muscle.
Cannabidiol (CBD) is a phytocannabinoid discovered in 1940. It is one of 113 identified cannabinoids in cannabis plants,along with tetrahydrocannabinol (THC),and accounts for up to 40% of the plant's extract. As of 2022,clinical research on CBD included studies related to the treatment of anxiety,addiction,psychosis,movement disorders,and pain,but there is insufficient high-quality evidence that cannabidiol is effective for these conditions. CBD is also sold as a herbal dietary supplement promoted with unproven claims of particular therapeutic effects.
Abner Joseph Mikva was an American politician,federal judge,and legal scholar. He was a member of the Democratic Party. After serving in the Illinois House of Representatives,Mikva ran for congress in 1966 but lost the primary to incumbent congressman Barrett O'Hara. In 1968,Mikva defeated O'Hara. Mikva served in the United States House of Representatives representing Illinois's 2nd congressional district (1969–1973) and 10th congressional district (1975–1979). He was appointed as a United States circuit judge of the United States Court of Appeals for the District of Columbia Circuit by President Jimmy Carter,serving from 1979 to 1994. He served as the White House Counsel from 1994 to 1995 during Bill Clinton's presidency. He was one of the few people in modern times to serve in the executive,legislative and judicial branches of the Federal government.
Frances Kathleen Oldham Kelsey was a Canadian-American pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA),she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals. Kelsey was the second woman to receive the President's Award for Distinguished Federal Civilian Service,awarded to her by John F. Kennedy in 1962.
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).
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.
David Aaron Kessler is an American pediatrician,attorney,author,and administrator serving as Chief Science Officer of the White House COVID-19 Response Team since 2021. Kessler was the commissioner of the Food and Drug Administration (FDA) from November 8,1990,to February 28,1997. He co-chaired the Biden-Harris transition’s COVID-19 Advisory Board from November 2020 to January 2021 and was the head of Operation Warp Speed,the U.S. government program to accelerate the development of COVID-19 vaccines and other treatments,from January to February 2021.
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 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. The commissioner is appointed by the president of the United States and must be confirmed by the Senate. The commissioner reports to the secretary of health and human services.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food,Drug,and Cosmetic Act as added to and amended by various Acts of Congress,including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA),as codified by 21 U.S.C. § 360bbb-3,to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term,but instead authorizes the FDA to facilitate availability of an unapproved product,or an unapproved use of an approved product,during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.
The Food and Drug Administration is a federal agency of the United States,formed in 1930.
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 the 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.
Tucatinib,sold under the brand name Tukysa,is an anticancer medication used for the treatment of HER2-positive breast cancer. It is a small molecule inhibitor of HER2. It was developed by Array BioPharma and licensed to Cascadian Therapeutics.
Richard A. Merrill was an American lawyer,government official,and academic administrator who served as the 7th dean of the University of Virginia School of Law and the chief counsel of the Food and Drug Administration from 1976 to 1978.
References
- ↑ Terry, Nicholas (September 8, 2017). "Lewis Grossman on 'The Week in Health Law' Podcast". Bill of Health. Retrieved 26 April 2020.
- ↑ Lazarus, David (February 10, 2017). "Column: Speedy drug approvals are risky, but drug companies have another idea that's just terrible". The Los Angeles Times. Retrieved 26 April 2020.
- ↑ "Lewis Grossman on 'The Week in Health Law' Podcast". Kennedy Institute of Ethics. Retrieved 26 April 2020.
- 1 2 3 4 5 "WEDDINGS; Lisa M. Rabin, Lewis Grossman". The New York Times. October 9, 1994. Retrieved 26 April 2020.
- 1 2 Campbell, Hunter (April 12, 2017). "2017-2018 LAPA Fellows include alumnus, health law specialist". The Daily Princetonian. Retrieved 27 April 2020.
- ↑ "Lewis Grossman". J Archive. Retrieved 26 April 2020.
- ↑ "Suzee Vlk, Lewis Grossman, Judith Seeger". TVDB. Retrieved 26 April 2020.
- ↑ "Daily Digest, Senate". Congressional Record. February 24, 1998. Retrieved 26 April 2020.
- ↑ "THE EVOLUTION OF FDA REGULATIONS AND THE RISE OF THE EMPOWERED CONSUMER". Drexel University. October 28, 2013. Retrieved 27 April 2020.
- ↑ Terry, Mark (October 22, 2018). "Former FDA Commissioners: Agency Should Be Independent". BioSpace. Retrieved 27 April 2020.
- ↑ "Under Obama, a renewed FDA, Los Angeles Times". Frameworks Institute. Retrieved 27 April 2020.