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The Pharmaceutical Supply Chain Defense and Enhancement Act was first introduced in 2020, not long after the start of the COVID-19 pandemic. The bill was… Warren, Smith reintroduce bill to ...
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.
The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate the ...
The Medicare Prescription Drug, Improvement, and Modernization Act, [1] also called the Medicare Modernization Act or MMA, is a federal law of the United States, enacted in 2003. [2] It produced the largest overhaul of Medicare in the public health program's 38-year history.
NEW YORK (Reuters) -The Pharmaceutical Research and Manufacturers of America (PhRMA), the leading industry lobby group, and two other organizations on Wednesday said they were suing the U.S ...
The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.
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 CREATES Act was opposed by Pharmaceutical Research and Manufacturers of America (PhRMA). [3] Opponents said the bill was not good solution to the issue of Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use, or "REMS with ETASU" processes. [9] These programs can include physician training, patient registries or follow-up ...