FDA's top management can't be accused of overstating the importance of the agency's new drug safety tools. But sponsors need to wake up to the reality: the REMS are a critical fact of drug development and marketing.
By Michael McCaughan
Maybe it’s the acronym. When Congress settled on the term Risk Evaluation & Mitigation Strategies as the catch-all term for...
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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.
