Pink Sheet Podcast: Adcoms Too Emotional, Pushing Gene Therapy Science, Congress Gets UFA Update
Executive Summary
Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.
You may also be interested in...
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
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.