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)
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The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web.