Unger Takes Over ODE I As Acting Director; Temple To Focus On Clinical Science Role
This article was originally published in The Pink Sheet Daily
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One of the US FDA’s most prominent review managers is retiring after nearly 25 years with the agency. Ellis Unger’s departure underscores a sense of transition in the leadership and mindset of the drug center.
FDA’s draft guidance on “Enrichment Strategies for Clinical Trials” fulfills an overdue goal from PDUFA IV. It also captures decades of wisdom from the agency’s senior drug review manager.
The company held an investor presentation 10 days before the meeting to rebut criticisms laid out in FDA’s briefing document about the droxidopa safety and efficacy data. Immediately following the meeting, Chelsea hosted an investor call, during which the company’s external cardiology consultant criticized the FDA clinical reviewer as “naive.”