Search results
Results from the WOW.Com Content Network
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 ...
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
This policy was later challenged in court following FDA approval of a food coloring manufactured with a compound known to be carcinogenic, after separate testing indicated that the food coloring itself did not cause cancer in test animals. The United States Court of Appeals for the Sixth Circuit upheld the FDA's approval of the food coloring. [36]
In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
Its manufacturing facility in Framingham, Massachusetts won the Facilities of the Year Award (FOYA) award in 2022. [4] The company’s lead program, exagamglogene autotemcel , or exa-cel (formerly CTX001), was granted regulatory approval by the US Food and Drug Administration (FDA) in December 2023.
Fermentation Suite. In 2006, Intralytix was the first company in the world to receive FDA/USDA approval for a bacteriophage-based food safety product, ListShield. [1]That same year, Intralytix was also the first company in the world to successfully assemble a Master Drug File (MDF) application with the FDA, and to manufacture and supply its phage product for the first-ever in the US human ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
MQSA requires facilities to "be accredited by an FDA-approved accreditation body." Currently the only nationally-approved body is the American College of Radiology (ACR). State-level alternatives to the ACR are the Arkansas Department of Health, Iowa Department of Public Health, and Texas Department of State Health Services.