FDA publishes NDA filing checklist to avoid application derailments
Regulatory NewsJoanne S. Eglovitch
Approval/marketing authorizationBiologics/ biosimilars/ vaccinesBiotechnologyCDERChemistry, Manufacturing and Controls (CMC)Clinical TrialsNew Drug Application (NDA)PharmaceuticalsPreclinical studyProduct developmentRegulatory Intelligence/PolicySubmission and registrationUnited StatesUS Food and Drug Administration (FDA)