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Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
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In 2002, the FDA transferred a number of biologically produced therapeutics to CDER. [8] CBER regulates a number of biologics-related products, including blood tests, computer software, and devices related to blood transfusion, which industry representatives would like to see handled by the much brisker Center for Devices and Radiological Health.
The FDA has its own requirements for animal research, known as Good Laboratory Practice, to demonstrate that any scientific data being collected in the development of a drug or medical device is ...
An animal testing laboratory at Elon Musk's Neuralink brain technology company was found to have "objectionable conditions or practices" by the Food and Drug Administration, which cited the ...
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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 ...
FDA officials have long voiced concerns about the accuracy of some tests, pointing to patients who have received inaccurate results for heart disease, Lyme disease and other conditions.