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Part of the problem was the CAFC's decision in Roche Products, Inc. v. Bolar Pharmaceutical Co., which interpreted existing U.S. law as prohibiting generic competitors from performing tests required for FDA approval using patented methods, until the patents expired. [2] In response, the Hatch-Waxman Act was negotiated and enacted. [3]
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.
This article needs to be updated.The reason given is: there was a significant revision to Japan's Pharmaceuticals and Medical Devices Act (PMD Act) in December 4, 2019 (令和 元 年12月 4日) and certain articles in this revised PMD Act took effect April 1, 2020, September 1, 2020, and August 1, 2021; other articles will take effect Dec. 1, 2022 (see also: https://www.natlawreview.com ...
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 ...
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005 (as part of Pub. L. 109–148 (text)), is a controversial tort liability shield intended to protect pharmaceutical manufacturers from financial risk in the event of a declared public health emergency.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
The Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91–513, 84 Stat. 1236, enacted October 27, 1970, is a United States federal law that, with subsequent modifications, requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs. [1]
It also reauthorizes the Prescription Drug User Fee Act. The PFUDA was first enacted in 1992 to allow the FDA to collect application fees from pharmaceutical companies when applying for approval for a drug. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007.