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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FDA’s draft guidance on “Enrichment Strategies for Clinical Trials” fulfills an overdue goal from PDUFA IV.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.”
FDA clinical science expert Robert Temple discusses how the Sentinel project – a drug data monitoring initiative – can support the agency’s postmarket drug safety investigations.