FDA Post-Marketing Study Compliance Efforts To Get HHS OIG Review
This article was originally published in The Pink Sheet Daily
Executive Summary
The HHS watchdog will also continue its look at generic drug facility inspections and supply chain oversight, according to its fiscal year 2015 work plan.
You may also be interested in...
JAMA Studies Provide More Ammunition For Trial Disclosure Reformers
JAMA studies focus on the high number of terminated and unreported trials, plus discrepancies in publicly reported trial results. Publication comes as the Institute of Medicine consults stakeholders about trial data sharing and ahead of new reporting laws in Europe.
FDA GMP “Surveillance” Will Link Quality, Compliance Information To Inspections
CDER’s Woodcock says the new database will drive risk-based inspection decisions.
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.