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.
Tubal ligation is a surgical procedure for female sterilization in which the fallopian tubes are permanently blocked, clipped or removed. This prevents the fertilization of eggs by sperm and thus the implantation of a fertilized egg. Tubal ligation is considered a permanent method of sterilization and birth control.
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. 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.
Labcorp Drug Development is a contract research organization (CRO) headquartered in Burlington, North Carolina, providing nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology industries. Formerly called Covance, the company is part of Labcorp, which employs more than 70,000 people worldwide. Labcorp Drug Development claims to provide the world's largest central laboratory network.
An approved drug is a medicinal preparation that has been validated for a therapeutic use by a ruling authority of a government. This process is usually specific by country, unless specified otherwise.
The pharmaceutical industry is one of the leading industries in the People's Republic of China, covering synthetic chemicals and drugs, prepared Chinese medicines, medical devices, apparatus and instruments, hygiene materials, packing materials, and pharmaceutical machinery. China has the second-largest pharmaceutical market in the world as of 2017 which is worth US$110 billion. China accounts for 20% of the world's population but only a small fraction of the global drug market. China's changing health-care environment is designed to extend basic health insurance to a larger portion of the population and give individuals greater access to products and services. Following the period of change, the pharmaceutical industry is expected to continue its expansion.
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.
Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation. The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction. Although designed to remain in place for a lifetime, it was approved based on short-term safety studies. Of the 745 women with implants in the original premarket studies, 92% were followed up at one year, and 25% for two years, for safety outcomes. A 2009 review concluded that Essure appeared safe and effective based on short-term studies, that it was less invasive and could be cheaper than laparoscopic bilateral tubal ligation. About 750,000 women have received the device worldwide.
Tubal reversal, also called tubal sterilization reversal, tubal ligation reversal, or microsurgical tubal reanastomosis, is a surgical procedure that can restore fertility to women after a tubal ligation. By rejoining the separated segments of the fallopian tube, tubal reversal can give women the chance to become pregnant again. In some cases, however, the separated segments cannot actually be reattached to each other. In some cases the remaining segment of tube needs to be re-implanted into the uterus. In other cases, when the end of the tube has been removed, a procedure called a neofimbrioplasty must be performed to recreate a functional end of the tube which can then act like the missing fimbria and retrieve the egg that has been released during ovulation.
Gadobutrol (INN) (Gd-DO3A-butrol) is a gadolinium-based MRI contrast agent (GBCA).
Obinutuzumab, sold under the brand name Gazyva among others, is a humanized anti-CD20 monoclonal antibody, originated by GlycArt Biotechnology AG and developed by Roche as a cancer treatment.
Bayer AG is a German multinational pharmaceutical and biotechnology company and is one of the largest pharmaceutical companies in the world. Headquartered in Leverkusen, Bayer's areas of business include pharmaceuticals, consumer healthcare products, agricultural chemicals, seeds and biotechnology products. The company is a component of the EURO STOXX 50 stock market index.
Tralokinumab sold under the brand names Adtralza (EU/UK) and Adbry (US) among others, is a human monoclonal antibody used for the treatment of atopic dermatitis. Tralokinumab targets the cytokine interleukin 13.
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.
GW Pharmaceuticals Limited is a British pharmaceutics company known for its multiple sclerosis treatment product nabiximols which was the first natural cannabis plant derivative to gain market approval in any country. Another cannabis-based product, Epidiolex, was approved for treatment of epilepsy by the US Food and Drug Administration in 2018. It is a subsidiary of Jazz Pharmaceuticals.
AMAG Pharmaceuticals, Inc. is an American pharmaceutical company developing products that treat iron deficiency anemia (IDA) in adult patients. The company was a publicly traded company listed on NASDAQ under the symbol "AMAG" until November 2020 when it was acquired by Covis Pharma.
QuidelOrtho Corporation is a major American manufacturer of diagnostic healthcare products that are sold worldwide.
Robert McKinnon Califf is an American cardiologist who currently serves as the 25th Commissioner of the Food and Drug Administration.
Spotlight Innovation Inc. is an American pharmaceutical holding company. The company currently maintains two subsidiaries: Caretta Therapeutics, Inc. and Celtic Biotech Iowa, Inc. Spotlight Innovation Inc. is based in Urbandale, Iowa and is publicly traded on the OTCQB marketplace under the stock ticker symbol, STLT.
Relief Therapeutics is a Swiss biopharmaceutical company based in Geneva. The company focuses on developing drugs for serious diseases with few or no existing treatment options. Its lead compound, RLF-100, is a synthetic form of a natural peptide that protects the lung. The company was incorporated as Relief Therapeutics Holdings AG (RFLB.S) and listed on the SIX Swiss Exchange in 2016.
