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The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...
This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. [1] It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate. [2]
To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. Announced in: the 113th United States Congress: Sponsored by: Rep. Fred Upton (R, MI-6) Number of co-sponsors: 10: Citations; Public law: Pub. L. 113–54 (text) Codification; Acts affected
Pharmacy Benefit Managers reform, including delinking PBM profits from high drug prices, enjoys broad bipartisan support. Congress can lower drug prices with new laws to reform Pharmacy Benefits ...
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.
In community pharmacy Settings, Federal Law (OBRA-90) requires drug utilization review for patients receiving medication through Medicaid. [8] Then Drug utilization review was common in society. Recognizing that Medicaid recipients faced similar risks in the 1980s, Congress provided for the ambulatory drug utilization review under the Omnibus ...
Poison Prevention Packaging Act of 1970; Long title: An Act to amend the Federal Hazardous Substances Act to provide for child resistant packaging to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting a hazardous substance, and for other purposes.
Opinion: Restricting pharmacy benefit managers' practices won't reduce prescription drug costs or improve health outcomes. New law requires $10 dispensing fee and will cost Kentuckians at the pharmacy