Giroir's memo to FDA staff also says intends to coordinate with prior acting commissioner Norman Sharpless to ensure current activities continue.
Adm. Brett Giroir expects to maintain the US Food and Drug Administration's connection with Norman Sharpless during his tenure as acting commissioner, a role Giroir does not appear to believe he will have for long.
In a memo to staff dated 4 November, Giroir, who had been named acting FDA commissioner three days earlier, noted...
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The FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad, and Commissioner Martin Makary get along?
In an email to staff filled with unsupported accusations about the quality of the center’s research, CBER Director Vinay Prasad said no resources or time should be spent on ongoing projects started before he joined the FDA until discussed with him.
Merck, Lilly, and Johnson & Johnson are some of the pharma companies who have snagged the many staff leaving the FDA’s oncology positions. The Pink Sheet estimates CDER’s oncology division is operating with about a 20% vacancy rate.
Five of the six winners of the US FDA’s second batch of Commissioner’s National Priority Vouchers are for secondary indications. That is no accident, Commissioner Makary says.
A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.
EU drug regulators are taking steps to strengthen their assessment capacity by widening access to specialists from outside the EU/EEA.
Five of the six winners of the US FDA’s second batch of Commissioner’s National Priority Vouchers are for secondary indications. That is no accident, Commissioner Makary says.
