House Compounding Bill Would Regulate “Outsourcing Facilities” With Volume Limits
This article was originally published in The Pink Sheet Daily
Executive Summary
Reps. Griffith, DeGette, and Green co-sponsor bill to improve FDA oversight of compounding with some provisions similar to Senate bill, possibly opening door to compromise.
You may also be interested in...
Track-and-Trace Bill Clears House With New Electronic Labeling Language
Safeguarding America’s Pharmaceuticals Act passes on suspension calendar, but likely sets up fight with Senate in conference.
Neonatal Drug Development Could Benefit From Rare Disease Experience
Early parent involvement in drug development and clinical trial design could improve recruitment and outcomes, stakeholders argue.
US FDA Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval
Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.