WASHINGTON (CN) – Companies making generic drugs must submit data for all tests done and relied upon when applying for approval by the FDA, including those with negative results, beginning July 15.
They also will have to report annually on all studies done or obtained after the generic drug has been released to the public.
Makers of generics generally may rely on studies done by the brand-name drug maker, but also must show that the generic is “biologically equivalent” to the brand-name drug, or, is of the same strength, goes into the body at the same rate, and is expected to have the same therapeutic effect.
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