FDA Drug Detention Regulation Follows Devices Oversight Model
This article was originally published in The Tan Sheet
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.
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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.
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.
The Senate is expected to vote this week on the bipartisan compromise of the FDA user fee and reform legislation, which the House overwhelmingly passed in a voice vote June 20. Senate review of the bill will coincide with the Supreme Court’s decision on the health care reform law.