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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
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 ...
505 is the description of the drug approval process; 510(k) is the section that allows for clearance of class II medical devices; 515 is the description of the (class III) device approval process; VI. Cosmetics VII. General Authority 704 allows inspections of regulated entities. Inspection results are reported on Form 483. VIII. Imports and ...
A home kit designed to help people conceive has been given Class II clearance by the Food and Drug Administration. The Mosie Baby Kit is now the only FDA-cleared over-the-counter kit for ...
The government agency is tightening its standards for "healthy" claims. And for the first time in 30 years, its labeling rules will be updated to reflect new nutrition standards.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
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The Free and Secure Trade (FAST) program is a joint United States-Canadian program between the Canada Border Services Agency and the U.S. Customs and Border Protection. The FAST initiative offers pre-authorized importers, carriers and drivers expedited clearance for eligible goods, building on what Canada previously implemented under their ...