The US FDA may resort to using its bully pulpit to lessen REMS abuses that prevent generic entry.
Agency letters to brand companies indicating it is acceptable under a Risk Evaluation and Mitigation Strategy (REMS) to sell samples...
Commissioner Gottlieb says agency is considering publicizing letters it has written to brand companies indicating it would not violate a REMS to sell a generic company samples for testing.
The US FDA may resort to using its bully pulpit to lessen REMS abuses that prevent generic entry.
Agency letters to brand companies indicating it is acceptable under a Risk Evaluation and Mitigation Strategy (REMS) to sell samples...
The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.