EU Pharmaceutical Reform: A Delicate Negotiation
The European Commission may well be flexible over its proposals on data protection periods, but it is unlikely to give ground on plans to restructure the European Medicines Agency and to introduce a new temporary emergency marketing authorization, says lawyer Vincenzo Salvatore.
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The texts of the proposals cannot be formally presented to the European Parliament until they have been translated into all of the EU’s official languages.
Pink Sheet Podcast: Adcomm Rejects NurOwn For ALS, FDA In Shutdown Mode, Limited Price Negotiation Savings
Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug, the impact of a government shutdown on the agency, and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations.
Foreign tablets, active pharmaceutical ingredient residues and failed line clearance plagued operations at repackers that received FDA warning letters in FY 2023.