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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 ...
In certain situations, the agency may take other actions instead of, or concurrent with, a Warning Letter. For example: [3] The product is adulterated under Section 402(a)(3) or 402(a)(4) of the Act; There is a violation of cGMP; The product contains illegal pesticide residues; or; The product shows short contents, subpotency, or superpotency.
In 2010, the FDA's Division of Drug Marketing, Advertising and Communications issued a warning letter concerning two unbranded consumer targeted Web sites sponsored by Novartis Pharmaceuticals Corporation as the websites promoted a drug for an unapproved use, the websites failed to disclose the risks associated with the use of the drug and made ...
The FDA gave the company 15 working days to respond to the warning letter. This article originally appeared on Milwaukee Journal Sentinel: Brenntag Great Lakes receives FDA warning letter over ...
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
The FDA, in its letter on Wednesday, said the company was marketing kits which include certain misbranded piston syringes made by China's Jiangsu Shenli Medical Production and neither had approval ...
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...
Warnings - covers possible serious side effects that may occur (e.g., boxed warning) Precautions - explains how to use the medication safely including physical impairments, food ( grapefruits ) and drug interactions; for example "Do not drink alcohol while taking this medication" or "Do not take this medication if you are currently taking MAOI ...