Pink Sheet Podcast: Makena's Accelerated Approval Questions, Woodcock On Biobetters, Singulair's Safety Issues
Executive Summary
Pink Sheet reporters discuss the upcoming Makena advisory committee meeting, Janet Woodcock's recent comments on the biosimilar market, and options for new safety communications for Singulair.
You may also be interested in...
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.
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.