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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 ...
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
One exception occurred during the 2010 Swine Flu Epidemic when the FDA authorized expired Tamiflu based on SLEP Data. [9]The US FDA is able to extend the shelf life of drugs throughout national, state, local, tribal, and territorial stockpiles through two legal means: by issuing an Emergency Use Authorization on using a drug past its expiration date (which is legally an unapproved use of a ...
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.
The FDA is also working on a symbol that can be put on packages to help consumers more easily identify foods that are considered healthy and developing a plan for nutrition labeling that would go ...
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as:
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 ...
(The Center Square) – The Food and Drug Administration is proposing front-of-package warning labels that detail the calorie, fat, sugar and salt content of processed food and drink products. Sen.