Published on: 2016-06886. Final rule; technical amendment. 2016-06886. Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical Amendment
Published on: 2010-24296. Final rule. 2010-24296. Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans