FDA Appeals Maryland Court Ruling that Accelerated Substantial Equivalence Deadlines

The U.S. Food & Drug Administration (FDA) has appealed a ruling from a federal court in Maryland that changed the date substantial equivalence submissions are due from August 2021 to May 12, 2020. Attorneys for the Department of Justice filed a short notice of appeal in American Academy of Pediatrics, et al. v. United States Food […] The post FDA Appeals Maryland Court Ruling that Accelerated Substantial Equivalence Deadlines appeared first on halfwheel.