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Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X; Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5; Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828 ...
Title II of the act, the Drug Supply Chain Security Act (DSCSA), established requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. Under DSCSA, the Secretary is required to establish standards for the exchange of transaction documentation, including transaction information ...
The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs.
Medicare Modernization Act — includes PDF file of the actual text of the law. Medicare.gov — the official website for people with Medicare Medicare Modernization Act at Medicare.gov; Prescription Drug Coverage homepage at Medicare.gov — a central location for Medicare's web-based information about the Part D benefit
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.
The EU pharmaceutical legislation refers directly to the Ph. Eur. and to other activities for which the EDQM is responsible (e.g. the Certification procedure or "CEP" and the OMCL Network – see below), demonstrating the shared commitment of the European organisations to public health protection.
The 1200 series consists of rules primarily based in laws other than the Food, Drug, and Cosmetic Act: 1240 Rules promulgated under 361 of the Public Health Service Act on interstate control of communicable disease, such as: Requirements for pasteurization of milk; Interstate shipment of turtles as pets.
Drug legislation in both the EU and US were passed in order to assure drug safety and efficacy. Of note, increased regulations and standards for testing actually led to greater innovation in pharmaceutical research in the 1960s, despite greater preclinical and clinical standards. [ 6 ]