ANDA Renaissance: FDA Aims To Reduce Refuse-To-Receive Actions
This article was originally published in The Pink Sheet Daily
Executive Summary
About to start GDUFA negotiations, agency wants to enhance communication with sponsors to avoid returning their applications.
You may also be interested in...
GDUFA II Negotiations: Contract Manufacturers Gain Seat At Table
Generic user fees could be segmented further by addition of new group.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.
US FDA Hopes Food, Inspection Office Reorg Bolsters Innovative Clinical Trial Adoption
Ensuring inspectors understand the innovative trial designs in use before an inspection will be important to increasing industry confidence in their use, CDER Director Patrizia Cavazzoni said.