Slide 1 Good Clinical Practices and FDA Inspections Patricia Holobaugh Chief, Bioresearch Monitoring Branch Division of Inspections and Surveillance Office of Compliance…
Slide 1 Investigational New Drug (IND) Orientation Responsibilities of IND Sponsor-Investigators MICHR IND/IDE Assistance Program (MIAP) Slide 2 Responsibilities of IND Sponsor-Investigators…