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Signed into law by President George W. Bush on September 27, 2007. President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA.
Pharmacovigilance ( PV, or PhV ), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1] : 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to ...
Drug reference standard. A drug reference standard or pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products. [1]
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]
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration and the Ministry of Health, Labour and Welfare (Japan ...
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) 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 ...
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 Drug Quality and Security Act ( H.R. 3204) is a law that amended the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs. [1] The bill was written in response to the New England Compounding Center meningitis outbreak that took place in ...