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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 ...
Fisher-Wallace renamed the device as the FW-100 Cranial Stimulator Device, and it was approved for marketing by Health Canada in 2014 under Licence No. 92984; in 2015 Health Canada received a complaint about Fisher Wallace's marketing on its website and sent an enforcement letter concerning the false marketing, which the company corrected. [8]
Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines ...
FDA preemption is the legal theory in the United States that products licensed or otherwise approved for use by the Food and Drug Administration (FDA) are exempt from various state efforts to preclude their use. It has been raised as a counter to both direct efforts to ban such products, and as a defense against tort claims regarding such ...
Under current Prescription Drug User Fee Act targets, the FDA aims to complete and act upon reviews of priority drugs within six months instead of the standard ten-month review period. Actual FDA review timelines, however, can be longer than the target PDUFA review periods, particularly for new products that haven't previously been approved for ...
Oz hired an independent toxicology laboratory, EMSL, and found arsenic levels in some samples to be above the limit the U.S. Food and Drug Administration (FDA) allows in drinking water. The FDA said "there is currently no evidence to suggest a public health risk", and criticized the emphasis on measurements of total arsenic without ...
The online distribution of counterfeit medicines has been growing during the last decades. The role of Internet as an unregulated medicine market is the main reasons behind this phenomenon, especially the effectiveness of "spam" as a tool for advertising and promoting these products.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.