BD agrees to settle most of its hernia mesh litigation (MedTech Dive)
Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices (FDA Law Blog)
Government, Regulatory & Legal
Becton Dickinson agrees to settle about 38,000 hernia mesh suits (Reuters)
Hospital at Home: Medicare report shows how the experiment is going (STAT)
US CDC warns of overdose risk from fake prescription medicines online (Reuters)
To aid addiction treatment, lawmakers tell DEA to back off buprenorphine enforcement (STAT)
Patient/CMS Roundtables For Medicare-Negotiated Drugs Will Be Interactive, But Not Public Next Time (Pink Sheet)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
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The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and purchasing, and complaint handling and feedback.
The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving proposals designed to tackle shortages of key medicines closer to law.