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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
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 ...
Medical Device Amendments of 1976; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes. Enacted by: the 94th United States Congress: Effective: May 28, 1976: Citations; Public law: 94-295: Statutes at Large: 90 Stat ...
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
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 ...
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 ...
The Sunshine Act requires manufacturers of drugs, medical devices, biological and medical supplies covered by the three federal health care programs Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) to collect and track all financial relationships with physicians and teaching hospitals and to report these data to the Centers for Medicare and Medicaid Services (CMS).