Greenleaf Health, an FDA regulatory consulting firm providing strategic and technical guidance to pharmaceutical and medical device companies, announced that John Jenkins, M.D., has joined the firm as principal, Drug and Biological Products.

A 25-year veteran of the FDA, Jenkins will lead a team of experts to assist clients with their drug development programs from the early stages of product development through to regulatory submission and post-approval requirements. Jenkins most recently was director, Office of New Drugs (OND) within the FDA’s Center for Drug Evaluation and Research (CDER) where he oversaw the review of thousands of new drug applications and biological licensing applications.

“No one is more qualified than John to provide our clients strategic and technical guidance on FDA’s regulatory process for drug and biological product development,” said Patrick Ronan, CEO of Greenleaf Health. “Our experts at Greenleaf, who have a combined total of more than 200 years of FDA experience, help our clients navigate complex regulatory challenges. John’s knowledge and experience in this area are unrivaled, and he makes a great addition to our team.”

Jenkins started his FDA career as a medical officer in the Division of Oncology and Pulmonary Drug Products and he held several leadership positions including director of the Division of Pulmonary Drug Products and director of the Office of Drug Evaluation II. He was a critical figure in the development and implementation of programs under the Prescription Drug User Fee Act (PDUFA) and played a leading role in implementing CDER’s biosimilar biologics program.

Board certified in internal medicine and pulmonary diseases, Jenkins started his career as a staff physician at Hunter Holms McGuire VA Medical Center in Richmond, Va., and was assistant professor of pulmonary and critical care medicine at the Medical College of Virginia (MCV).