HHS regulatory agenda for 2021 is light on new proposed and final FDA rules
The impact of the coronavirus on the FDA’s work plans is evident in the latest semi-annual regulatory agenda for HHS, which includes only two new biopharma-related proposed rules and one final rule.
The two proposed rules center on one that seeks to change FDA medication guide regulations and another to clarify FDA’s study conduct expectations for analytical and clinical pharmacology, bioavailability (BA) and bioequivalence (BE) studies.
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