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The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
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 act also codified FDA regulations and practice to increase patient access to experimental drugs and medical devices and to accelerate review of important new medications. In addition, the law provided for an expanded database on clinical trials, ClinicalTrials.gov. [7]
In the mid-1970s, 13 of the 14 drugs the FDA saw as most important to approve were on the market in other countries before the United States. [13] As part of the U.S. Public Health Service reorganizations of 1966–1973, FDA became part of the Public Health Service (PHS) within the Department of Health, Education, and Welfare in 1968. It was ...
A new rule from the Food and Drug Administration (FDA) will update what it means for food to be labeled “healthy” for the first time in 30 years, a move that aligns with current nutrition ...
In 1982, the organizational units at the FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH). Former leaders of CDRH [15] Jeffrey Shuren, M.D., J.D., CDRH Director 2009 – 2024; Daniel Schultz M.D., CDRH Director 2004 – 2009
The FDA banned the use of red dye No. 3 in foods and medicines sold in the U.S. because it has been shown to cause cancer in rats. The action highlights the limits of a federal law known as the ...
Foods that claim to be "healthy" on their packaging will soon be subject to a new set of labeling guidelines, part of an effort by the U.S. Food and Drug Administration to help educate consumers ...