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The artificial sweetener aspartame has been the subject of several controversies since its initial approval by the U.S. Food and Drug Administration (FDA) in 1974. The FDA approval of aspartame was highly contested, beginning with suspicions of its involvement in brain cancer, [1] alleging that the quality of the initial research supporting its safety was inadequate and flawed, and that ...
In 2013, it was approved in Canada and by the U.S. Food and Drug Administration (FDA) to treat bipolar depression, either as monotherapy or adjunctively with lithium or valproate. [ 15 ] [ 16 ] It has no effect on manic symptoms and is more potent for treating major depressive disorder or depressive episodes associated with bipolar disorder.
This policy was later challenged in court following FDA approval of a food coloring manufactured with a compound known to be carcinogenic, after separate testing indicated that the food coloring itself did not cause cancer in test animals. The United States Court of Appeals for the Sixth Circuit upheld the FDA's approval of the food coloring. [36]
On January 15, the Food and Drug Administration (FDA) officially banned Red No. 3, a color additive used in food, beverages, and ingested drugs in the U.S.This decision comes almost three years ...
Medical foods are regulated by the US Food and Drug Administration under the Food Drug and Cosmetic Act regulations. 21 CFR 101.9(j) (8). [1]The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary ...
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the ...
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.
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