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.
Topiramate, sold under the brand name Topamax among others, is a medication used to treat epilepsy and prevent migraines. It has also been used in alcohol dependence and essential tremor. For epilepsy this includes treatment for generalized or focal seizures. It is taken orally.
Lindane, also known as gamma-hexachlorocyclohexane (γ-HCH), gammaxene, Gammallin and benzene hexachloride (BHC), is an organochlorine chemical and an isomer of hexachlorocyclohexane that has been used both as an agricultural insecticide and as a pharmaceutical treatment for lice and scabies.
Chelation therapy is a medical procedure that involves the administration of chelating agents to remove heavy metals from the body. Chelation therapy has a long history of use in clinical toxicology and remains in use for some very specific medical treatments, although it is administered under very careful medical supervision due to various inherent risks, including the mobilization of mercury and other metals through the brain and other parts of the body by the use of weak chelating agents that unbind with metals before elimination, exacerbating existing damage. To avoid mobilization, some practitioners of chelation use strong chelators, such as selenium, taken at low doses over a long period of time.
Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards. The FDA list of GRAS notices is updated approximately each month, as of 2021.
Mitragyna speciosa is a tropical evergreen tree in the coffee family native to Southeast Asia. It is indigenous to Cambodia, Thailand, Indonesia, Malaysia, Myanmar, and Papua New Guinea, where it has been used in herbal medicine since at least the 19th century. It has also historically been consumed via chewing, smoking, and as a tea. Kratom has opioid-like properties and some stimulant-like effects.
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
Oxaprozin, also known as oxaprozinum, is a nonsteroidal anti-inflammatory drug (NSAID), used to relieve the inflammation, swelling, stiffness, and joint pain associated with osteoarthritis and rheumatoid arthritis. Chemically, it is a propionic acid derivative. Safety and efficacy has been established in children over 6 years with juvenile rheumatoid arthritis only, and there is an increased risk of adverse reactions in the elderly population.
Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) of the oxicam class used to relieve the symptoms of painful inflammatory conditions like arthritis. Piroxicam works by preventing the production of endogenous prostaglandins which are involved in the mediation of pain, stiffness, tenderness and swelling. The medicine is available as capsules, tablets and, in some countries, as a prescription-free gel 0.5%. It is also available in a betadex formulation, which allows a more rapid absorption of piroxicam from the digestive tract. Piroxicam is one of the few NSAIDs that can be given parenteral routes.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved. Regulations are primarily at 21 CFR 312. Similar procedures are followed in the European Union, Japan, and Canada due to regulatory harmonization efforts by the International Council for Harmonisation.
Toxicogenomics is a subdiscipline of pharmacology that deals with the collection, interpretation, and storage of information about gene and protein activity within a particular cell or tissue of an organism in response to exposure to toxic substances. Toxicogenomics combines toxicology with genomics or other high-throughput molecular profiling technologies such as transcriptomics, proteomics and metabolomics. Toxicogenomics endeavors to elucidate the molecular mechanisms evolved in the expression of toxicity, and to derive molecular expression patterns that predict toxicity or the genetic susceptibility to it.
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived. These principles apply to the non-clinical safety testing of substances found in various products to ensure the quality and integrity of the safety data submitted to regulatory authorities globally.
Ambrisentan, sold under the brand name Letairis among others, is a drug used for the treatment of pulmonary hypertension. It is an endothelin receptor antagonist.
Blinatumomab, sold under the brand name Blincyto, and known informally as blina, is a biopharmaceutical medication used as a second-line treatment for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia. It belongs to a class of constructed monoclonal antibodies, bi-specific T-cell engagers (BiTEs), that exert action selectively and direct the human immune system to act against tumor cells. Blinatumomab specifically targets the CD19 antigen present on B cells. In December 2014, it was approved by the US Food and Drug Administration under the accelerated approval program; marketing authorization depended on the outcome of clinical trials that were ongoing at the time of approval. Blinatumomab is given via intravenous infusion.
Tecovirimat, sold under the brand name Tpoxx among others, is an antiviral medication with activity against orthopoxviruses such as smallpox and mpox. In 2018 it became the first antipoxviral drug approved in the United States.
'Jefferson also known as Jeff Springs and Jefferson Springs Station is an unincorporated community in the Pine Bluff metropolitan area of northwestern Jefferson County in the U.S. state of Arkansas. It is situated on the Union Pacific Railway (UP), 15.5 miles (24.9 km) northwest of Pine Bluff, the county seat, and is the home of the National Center for Toxicological Research (NCTR).
The Food and Drug Administration (FDA) of the Philippines, formerly the Bureau of Food and Drugs, is a health regulatory agency under the Department of Health created on 1963 by Republic Act No. 3720, amended on 1987 by Executive Order 175 otherwise known as the "Food, Drugs and Devices, and Cosmetics Act", and subsequently reorganized by Republic Act No. 9711 otherwise known as "The Food and Drug Administration Act of 2009". The agency is responsible for licensing, monitoring, and regulation of cosmetics, drugs, foods, household hazardous products, medical devices and electromagnetic radiation emitting devices, pesticides, tobacco and related products, and vaccines for safety, efficacy, and quality in the Republic of the Philippines.
The United States Biological Defense Program—in recent years also called the National Biodefense Strategy—refers to the collective effort by all levels of government, along with private enterprise and other stakeholders, in the United States to carry out biodefense activities.
Joseph F. Holson, an American scientist, business executive, and educator in the disciplines of toxicology and product development, served as President of WIL Research Laboratories for 20 years (1988-2008). He is known for his contributions to the fields of developmental and reproductive toxicology (DART), pharmacokinetics, and risk assessment, including extensive experience with study design, data interpretation, and interspecies extrapolation of health effects data. He has served in numerous U.S. EPA/FDA advisory committees and as an expert toxicology witness. He was elected to two National Academy of Sciences toxicology committees. Dr. Holson is an editor and author of the textbook Regulatory Toxicology and an author of two significant chapters in the textbook Developmental and Reproductive Toxicology: A Practical Approach, Second Edition. Two of his peer-reviewed articles were recognized by the Risk Assessment Specialty Section of the Society of Toxicology as the Outstanding Published Papers Demonstrating an Application of Risk Assessment. He is the first author to receive this award in consecutive years for publications produced with two separate sets of coauthors.
Pegvaliase, sold under the brand name Palynziq, is a medication used for the treatment of the genetic disease phenylketonuria. It is a phenylalanine (Phe)‑metabolizing enzyme. Chemically, it is a pegylated derivative of the enzyme phenylalanine ammonia-lyase that metabolizes phenylalanine to reduce its blood levels.
