US FDA's Robert Temple And Signatory Authority: Teacher And Back-Up
The widely respected agency veteran will still be able to sign off on applications in his new "consultant" role in the Office of New Drugs, in part to help with the increasing workload.
You may also be interested in...
UPDATED: Who Can Sign US FDA EUAs? Expect Center Directors And Their Deputies Going Forward
Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.
Has R&D Productivity Rebounded? US FDA Officials Think So
Record-setting pace of NME approvals is a cause for celebration. But is it a sign that drug industry R&D productivity has actually improved? The US FDA’s top drug review official thinks so – but the data aren’t yet clear.
Four Rules For Being A Consistent US FDA Reviewer From Peter Stein
Amid concerns Office of New Drugs reorganization will result in sponsors receiving conflicting advice, new director offers several items already contemplated to prevent such problems.