The problem with notified body (NB) capacity in the European Union is well known, but a recent survey of NBs suggests that more than 17,000 certificates for medical devices and active implanted devices issued under the legacy regulation are set to expire by the end of 2024. More troubling might be the fact that the number of standing applications dwarfs the number of completed applications by a ratio of more than four to one, a gap that continues to grow as calendar year 2022 unwinds.
With a 9-4 vote, the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee bucked FDA reviewers who delayed PDUFA dates, issued a complete response letter and two formal dispute resolution requests for Ardelyx Inc.’s tenapanor as a hyperphosphatemia therapy for adults on dialysis with chronic kidney disease (CKD).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apollomics, Ascletis, Canbridge, Depymed, Neurosense.
Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Biomind Everest, Immunogen, Junshi, Kineta, Neurosense, Zielbio, Zynerba.
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome approach to validating these systems. However, drug and device manufacturers registered concerns about a lack of clarity in the draft, including 23andMe Holding Co., which said the draft’s references to methods that merely “help to fulfill” validation requirements leave too much gray area to be helpful.
Acotec Scientific Holdings Ltd. obtained marketing approval from the U.S. FDA for its peripheral support catheter Vericor, designed to enhance access to peripheral vessels.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeye Health, Roche, Rockfield Medical Devices, Tyber Medical.
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