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- Medtronic recalls Harmony delivery catheter system after tip detachment riskMedtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve. The FDA classified the recall as th…
- FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networksThe FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…fda press · 1mo agoRegulatoryPositive