FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four months in operation.
FDA says it will start accepting applications on 2/1 for its new PreCheck Pilot program intended to boost domestic drug manufacturing capability.
FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four months in operation.
FDA says it will start accepting applications on 2/1 for its new PreCheck Pilot program intended to boost domestic drug manufacturing capability.
Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studies when determining biosimilarity in some instances.
Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran autogene, significantly reduced the risk of melanoma recurrence or death when used in combination with Merck’s Keytruda.
