ANDA Approvals: Is FDA Productivity Boost Permanent?
This article was originally published in The Pink Sheet Daily
Executive Summary
Fourth consecutive month of strong results suggests generic review function is back on track.
You may also be interested in...
GDUFA Stakeholder Deadline May Come After Negotiations Conclude
Generic drug user fee reauthorization talks remain on schedule and are expected to last about four months.
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Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.
US FDA Program Streamlining COVID-19 Treatment Development Still Working As Emergency Ends
Any program changes would not occur until after a thorough assessment, the agency said.