FDA Could Publish Drug GMP Data To Nudge Manufacturing Improvements
This article was originally published in The Tan Sheet
Executive Summary
Batch failure and other measures manufacturers commonly track could be aggregated into an industry-wide index FDA would use to help make inspection decisions. CDER compliance chief Howard Sklamberg says FDA wants more predictive measures to find quality issues, rather than lagging metrics such as recalls or adverse events.
You may also be interested in...
FDA To Create Quality Metrics To Help Fine-Tune Risk-Based Enforcement
FDA will work with stakeholders to identify quality indicators that drug firms would track and report to help the agency improve surveillance and fine-tune risk-based criteria for inspections and enforcement, FDA’s Sklamberg said. CDER’s Office of Compliance also is focused on improving supply chain oversight and clarifying contract manufacturer responsibilities.
FDA To Create Quality Metrics To Help Fine-Tune Risk-Based Enforcement
FDA will work with stakeholders to identify quality indicators that drug firms would track and report to help the agency improve surveillance and fine-tune risk-based criteria for inspections and enforcement, FDA’s Sklamberg said. CDER’s Office of Compliance also is focused on improving supply chain oversight and clarifying contract manufacturer responsibilities.
FDA Drug Detention Regulation Follows Devices Oversight Model
A proposed rule implementing new FDASIA authority to administratively detain drugs believed to be adulterated or misbranded largely mirrors regulations already in place for medical devices, FDA says.