Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

OMB 0910-0672

Latest Forms, Documents, and Supporting Material

Document Name
0672 Supporting Statement A 2016.pdf Supporting Statement A
312.32(c)(1)(iv); IND Safety Reports
312.32(c)(1)(ii) and (c)(1)(iii); IND Safety Reports
320.31(d); Bioavailability and Bioequivalence Safety Reports