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List of stringent regulatory authorities. A stringent regulatory authority ( SRA) is a national drug regulation authority which the World Health Organization (WHO) considers to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of drugs and vaccines for marketing authorization. [1]
Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.
PUB, Singapore's National Water Agency, commonly known as PUB, an acronym for Public Utilities Board, is a statutory board under the Ministry of Sustainability and the Environment of the Government of Singapore responsible for ensuring a sustainable and efficient water supply in Singapore. PUB regulates and oversees the country's entire water ...
Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. Drug companies seeking to sell a drug in the United States must first test it.
In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...
The FDA later clarified that it has not approved any therapeutics or drugs to treat COVID-19, but that studies were underway to see if chloroquine could be effective in treatment of COVID-19. [146] [147] Following Trump's claim, panic buying of chloroquine was reported from many countries in Africa, Latin America and South Asia.
The FDA is continuing to pursue additional research to resolve these uncertainties." Yet on 17 July 2012, the FDA banned BPA from baby bottles and sippy cups. A FDA spokesman said the agency's action was not based on safety concerns and that "the agency continues to support the safety of BPA for use in products that hold food."