On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Supreme Court Reverses D.C. Circuit in Medicare Equitable Tolling Case
The D.C. District Court dismissed the hospitals’ claims because the statute did not suggest that Congress intended to authorize equitable tolling. On appeal, the D.C. Court of Appeals reversed, finding that there is a presumption that equitable tolling is permitted and that there was no indication that Congress intended to disallow tolling in this particular statutory scheme.
In its review, the Supreme Court first considered whether the 180-day statutory time limit for appeal to the PRRB is jurisdictional or whether it “is most sensibly characterized as a nonjurisdictional prescription.” The Court concluded that the filing deadline is not jurisdictional. The Court then held that HHS acted within the scope of its authority when it established a three year “outer limit” for appeals to the PRRB. Finally, the Court reversed the D.C. Circuit on the equitable tolling issue, holding that the presumption of the permissibility of equitable tolling has never been extended to an agency’s internal appeals deadlines and that there was no reason to think that Congress intended for equitable tolling to be allowable in this context.
The Supreme Court heard oral argument in this case on December 4, 2012.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017