FDA Hiring Challenges Help Drive Commissioner Hamburg's Reorganization
FDA's troubled interaction with the HHS personnel system is driving some of the restructuring that Commissioner Margaret Hamburg has proposed for her office
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As Congress debates increased funding and other steps to improve FDA oversight of imported drugs, the agency plans to hire 1,317 people in the next six months to bring staff numbers up to their full authorized levels
Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings
Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.
US FDA commissioner tells J.P. Morgan conference that the agency, industry, and the entire healthcare system need to change ‘at the same time’ in order for clinical trials to improve.