FDA Among Regulatory Authorities Reeling From Brexit Bombshell
This article was originally published in The Rose Sheet
Executive Summary
Commissioner Robert Califf says FDA has no firm plan but will “react to whatever happens” following the UK’s momentous decision to leave the EU. The European Medicines Agency also is taking a wait-and-see approach, while regulated industries brace for potential compliance, R&D and IP challenges in Brexit’s aftermath.
You may also be interested in...
‘This Is The Time’ For Industry To Advocate TPP Approval – PCPC
The Trans-Pacific Partnership was high among the Personal Care Products Council’s priorities during its recent Lobby Day on Capitol Hill. The trade group’s Executive VP, Global Affairs Francine Lamoriello discussed the trade deal’s promise with the Rose Sheet while acknowledging the challenges it faces in the current political climate.
US FDA Hopes Food, Inspection Office Reorg Bolsters Innovative Clinical Trial Adoption
Ensuring inspectors understand the innovative trial designs in use before an inspection will be important to increasing industry confidence in their use, CDER Director Patrizia Cavazzoni said.
US FDA's CDER Creates Quantitative Medicine Center Of Excellence; Job Includes AI Oversight
The group will coordinate quantitative medicine issues throughout the FDA's Center for Drug Evaluation and Research to help streamline drug development.