FDA: Don’t Let GDUFA DMF Assessments Delay ANDAs
This article was originally published in The Gold Sheet
Executive Summary
Generics manufacturers and their active substance suppliers should take steps to protect ANDAs from delays that new user fee requirements could cause, FDA official says. FDA’s new drug master file (DMF) review team will play a key role in keeping the new DMF completeness assessments from delaying ANDA filings.
You may also be interested in...
Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication
Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.
PIC/S: How Inspectorates Should Assess Pharma Quality Systems For Changes
Draft recommendation offers path to ICH Q12 regulatory relief.
Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges
Accelerating post-approval change oversight by focusing on ‘established conditions’ means trusting pharmaceutical quality management systems. But how?
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: