Federal News Update: FDA Trial Policy Changes and Q2 Health Policy Outlook
Emma Davidson
By Patrick Cooney, for AMRC
FEDERAL AGENCY NEWS
Single Pivotal Trial for Drug Approvals
Reaction from Congress has been muted since the U.S. Food and Drug Administration (FDA) announced its decision to move toward a single pivotal trial for drug approvals. No new legislation has been introduced, but several lawmakers have expressed scrutiny of FDA decision-making more broadly, which could extend to this change. At this stage, congressional reaction appears to be cautious oversight rather than...
