Product pre-approval inspections, vaccines and plasma-derived products are on the discussion agenda as the US-EU mutual recognition agreement takes full effect.
US and EU authorities are working to expand their mutual recognition agreement on pharmaceutical inspections beyond the current core of routine facility surveillance, now that the MRA has become final.
Under the agreement, the US Food and Drug Administration needed to assess the capabilities of EU member state inspectorates and...
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
