FDA Knows Its Own Strength—and It Includes Concentration
FDA Law Blog: Biosimilars
FEBRUARY 26, 2024
This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. FDA explained that its bioequivalence regulations at 21 C.F.R. Those regulations break “concentration” out from strength but only in certain contexts. mg) and the concentration (e.g.,
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