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Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studies when determining b...
Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Time Oncology Review pr...
FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four months in operation.
Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information, warning that the cu...
FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.
FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoints in multiple myelo...
Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compounded forms of its sema...
