FDA’s Rx Administrative Detention Reg Coming, But Not For A Little While
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency asks for stakeholder comments in advance of issuing a proposed rule on its new authority to detain potentially misbranded or adulterated drugs found during inspections, which was among FDASIA-mandated supply chain security improvements.
You may also be interested in...
FDA’s Anti-Counterfeit Strategy Gets Advisory Committee Review
Implications for pharma’s compliance burden may not be too far down the line as agency turns to Risk Communication Advisory Committee for techniques to encourage safe drug purchasing practices.
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.
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.