‘Stop Fighting Us’ On Inspections, US FDA’s Califf Tells Industry; Foods Modernization Will Bring ‘Big Change’ To Drug Quality Systems
Executive Summary
Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.
You may also be interested in...
Is It Time To Promote US FDA’s Biosimilars Office Out Of OND?
Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?
Is It Time To Promote US FDA’s Biosimilars Office Out Of OND?
Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?
US FDA Drug Center Medical Officer Hiring ‘Doing Well’
CDER Director Cavazzoni is seeing ‘net gains’ in hiring, including in key areas like medical officers. The agency still has lagging areas of need, like statisticians and inspector/investigators.