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insights.citeline.com US FDA Names Permanent CDER, CBER Directors, Creates AI Deputy Commissioner Post Michael Davis and Karim Mikhail get permanent titles after months in acting roles, but their tenure may hinge on whether commissioner nominee Heidi Overton is confirmed and whether there are other... View quoted post on X
insights.citeline.com US FDA’s New Complete Response Letters Emphasize Quality, Facility Issues The agency’s temporary pause in releasing CRLs, initiated in April, ended when it posted 14 new letters, although only a few cited clinical, clinical pharmacology and statistical deficiencies. 
insights.citeline.com HHS Considering US FDA Reorganization With Medical Products Chief Overseeing Centers The new position would oversee the drugs, devices and biologics centers, similar to the deputy commissioner for medical products and tobacco position that Margaret Hamburg created and Scott Gottlieb... Going to @US_FDA's public mtg on the NPV program today? Make sure to check out the @PharmaPinkSheet preview stories from @MaaishaO: insights.citeline.com/pink-sheet/pat…View quoted post on X
