Hamburg, The Atypical Commissioner, Receives Atypically Fond Farewell
This article was originally published in The Tan Sheet
Executive Summary
Margaret Hamburg’s background in public health, as opposed to academic medicine, was off-putting to some in pharma initially, but she leaves the agency in March with high drug approval numbers, initiatives to improve the OTC monograph and switch programs and increased enforcement in the supplement manufacturing arena.
You may also be interested in...
FDA Lands Duke’s Califf As Top Deputy, Potential Next Commissioner
Renowned cardiologist and clinical trialist Robert Califf will join FDA in February as deputy commissioner for medical products and tobacco.
‘Breakthrough’ Drugs Get ‘Road-MaPP’ – Complete With Communication Timetable
CDER Manual of Policy and Procedures describes specific actions FDA review staff will take once a product has received “breakthrough therapy” designation, with an emphasis on more meetings, more frequently.
FDA’s Acting Chief Scientist Offers Vaccine Continuity As Goodman Departs
Jesse Goodman will become director of Georgetown University’s new Center on Medical Product Access, Safety and Stewardship while Stephen Ostroff steps up as FDA’s Acting Chief Scientist.