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Parting thoughts

John Jenkins discusses lessons learned in 25 years at FDA

Few people have done more to shape how FDA reviews drugs than John Jenkins, who is resigning in January as director of the Office of New Drugs at the Center for Drug Evaluation and Research. Five FDA commissioners have led the agency during the 15 years Jenkins has directed OND, but for the companies that develop drugs and the broader community interested in drug regulation, the most important decisions have been made by a handful of civil servants like Jenkins who lead the agency’s core activities year after year.

Jenkins led the transformation of the agency into the world’s most efficient reviewer of new drugs. He created and managed systems that ensure FDA’s compliance with PDUFA commitments, including review action goals. He has been responsible for a staff of over 1,000 that performs more detailed reviews of drug applications, holds more meetings with drug sponsors and is responsible for more first-in-world approvals than any other regulatory agency.

Jenkins also has been at the center of controversies that have swept over FDA like tsunamis, from the tidal surge

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