மருந்து லேபிளிங் News Today : Breaking News, Live Updates & Top Stories | Vimarsana

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On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect the regulation of generic drugs and biosimilar medicines by the U.S. Food and Drug Administration (FDA).
Generic Drug Labeling
: The new Section 530D of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), added in Section 324 of Division BB of the Act, creates a process by which the FDA may determine whether it would benefit the public health to update the generic drug labeling at any point after the brand reference-listed drug is withdrawn for reasons other than safety or efficacy (i.e., commercial reasons). In general, FDA can use this process for such drugs when (1) there is new scientific evidence available pertaining to new or existing conditions of use that is not ....

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