GDUFA III Talks Completed
Fees will Fund Inspection, Complex Generic Improvements
Executive Summary
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
You may also be interested in...
FDA Seeks New Generics Chief As Choe Moves On
The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.
Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research
ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.
Growing Complex Generic Application Load May Force US FDA Staffing Changes
Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.