The digital IND/NDA/BLA: Generative AI for creating regulatory documents
RF QuarterlyMeredith Brown-Tuttle, FRAPS, RAC • Jay H. Mashburn, PhD, RPh • Halee Staggs, MS
Artificial intelligence/machine learning (AI/ML)Biologics License Application (BLA)Biologics/ biosimilars/ vaccinesGlobalNew Drug Application (NDA)PharmaceuticalsRegulatory writing/documentationTechnical documentationUnited States