FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for retail sales approval (MedTech Dive)
BD begins tender offers for up to $500M in debt to advance repayment strategy (Medtech Dive)
Government, Regulatory & Legal
Eight Indicted In Alleged Genetic Testing Fraud (MedTech Insight)
Medtronic Settles Man’s Suit Over Alleged Pacemaker Defect (Bloomberg)
Viatris Must Face Novo Nordisk Ozempic Patent Claims in Delaware (Bloomberg)
Karyopharm’a Win Over Investors on Cancer Drug Data Affirmed (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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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.