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The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices.It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union.
inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
Olipudase alfa was approved for medical use in Japan in March 2022. [6]In May 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Xenpozyme, intended for the treatment of non-central nervous system (CNS) manifestations of acid ...
Pfizer’s lung cancer drug Lorbrena can extend life for patients with a rare form of the disease for years longer than other drugs, according to new research published Friday.
The new detail suggests the Army helicopter was flying above 200 feet (61 meters), the maximum altitude for the route it was using. Preliminary data indicates the control tower's radar showed the ...
Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world.
The lawsuit against Sean “Diddy” Combs and Jay-Z over the alleged rape of a 13-year-old girl in 2000 has been dismissed by the attorney representing the Jane Doe, according to a court filing ...
Teriparatide, sold under the brand name Forteo, is a form of parathyroid hormone (PTH) consisting of the first 34 amino acids, which is the bioactive portion of the hormone. [13] It is an effective anabolic (promoting bone formation) agent [ 15 ] used in the treatment of some forms of osteoporosis .