Jenkins' Retirement From US FDA Was Several Years In The Making
Outgoing Office of New Drugs director dismisses speculation that his decision to leave the agency was related to events surrounding Sarepta's controversial Exondys 51 approval.
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OND will grow to eight offices and 27 clinical divisions, which is slightly different than an early proposal.
Uncertainty about Brexit's impact on the FDA-EMA mutual recognition agreement are among issues worrying regulators as countdown continues to the UK's departure from the EU.
Peter Stein is a familiar face within OND and has been working alongside CDER Director Janet Woodcock on the proposed “modernization” of OND. As a previous recruit from outside FDA, Stein has had time to make the key connections and adjustments to working inside government.