GMP Flexibility For Compounders Signaled In FDA Draft Guidance
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency seeks comments on how to minimize burden of some testing requirements for registered outsourcing facilities.
You may also be interested in...
FDA Compounder Inspections May Help Set New Enforcement Standard
Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.
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Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.