Perspectives on the draft ICH-M10 guidance: an interview with John Kadavil

Biography Dr Kadavil received his bachelor's degree in biochemistry from the University of Maryland, Baltimore County. He then received his PhD in molecular pharmacology and experimental therapeutics from the University of Maryland, Baltimore, School of Medicine. Following his PhD, he joined the US FDA as a pharmacologist. He first worked in the Office of Scientific Investigations - Division of Bioequivalence & Good Laboratory Practice under the Office of Compliance at CDER. During his 8 years at the Office of Scientific Investigations, he conducted foreign and domestic bioanalytical and clinical inspections for bioequivalence, bioavailability, pharmacokinetic and GLP studies. In 2011, he joined the Division of Human Food Safety at CVM as a pharmacologist, where he conducted reviews of residue chemistry studies and directed method trials. In 2014, he returned to CDER to become the team lead for the Collaboration, Risk Evaluation and Surveillance Team under the Office of Study Integrity and Surveillance. In September 2018, he became the Deputy Director for the Division of Generic Drug Bioequivalence Evaluation in Office of Study Integrity and Surveillance. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis, at the AAPS ICH-M10 Public Consultation Workshop (MD, USA).