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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.
It requires the FDA to submit an annual report to congressional committees that includes: (1) the number of devices approved in the preceding year for which there is a pediatric subpopulation that suffers from the disease; (2) the number of approved devices labeled for use in pediatric patients; (3) the number of fee-exempt devices approved ...
The law abolishes the long-standing prohibition of broadcasting by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to circulate peer-reviewed journal articles about an off-label indication of its product, providing the company is also committing itself to file proof of research within a ...
U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus. Thursday’s approval of ...
U.S. FDA approves Gilead's long-acting HIV drug Sunlenca December 22, 2022 at 11:26 AM FILE PHOTO: The logo of Gilead Sciences Inc pharmaceutical company is seen in Oceanside, California
By a provider concerning an FDA-regulated product or activity, By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA-regulated product or activity, or; By a contractor acting on behalf of the FDA or entity for these purposes; Law enforcement — PSWP may be disclosed to law enforcement personnel
On the eve of the Republican National Convention, Food and Drug Administration Commissioner Dr. Stephen Hahn announced that the FDA had issued emergency use authorization for investigational ...
Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to facilitate the development of drugs for rare diseases and conditions, and for other purposes. Enacted by: the 97th United States Congress: Effective: January 4, 1983: Citations; Public law: 97-414: Statutes at Large: 96 Stat. 2049: Codification; Acts amended: Federal Food ...