Of all the controversies surrounding the FDA, the agency’s reliance on user fees and its use of accelerated review of therapies might be the most consistent sources of public angst. Coleen Klasmeier, a partner of Sidley Austin LLP, told BioWorld that while she is not particularly concerned about regulatory capture stemming from FDA reliance on user fees, it may be appropriate to ask whether the drug premarket review process leaves FDA staff with more confidence in a new drug application than the data would seem to suggest.
Medtronic plc snagged FDA premarket approval for its recharge-free implantable neurostimulator (INS), Vanta, for patients with intractable pain. The spinal cord stimulator offers up to 11 years of device life, with optimal programming. That represents a 10% improvement on the Dublin-based company’s previous longest-lasting INS, Primeadvanced, and a near doubling of device life compared to Abbott Laboratories’ Proclaim and Boston Scientific Corp.’s Wavewriter Alpha, using the settings recommended in the clinician manuals.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Avita Medical, Canon Medical, Desktop Health, Medtronic, Neurescue, Nuvo Group.
Suzhou Zelgen Biopharmaceuticals Co. Ltd. won approval from China’s NMPA for Zepsun (donafenib tosylate) to treat patients with unresectable hepatocellular carcinoma who have not received systemic treatment. The small-molecule drug, independently developed by Zelgen, is a multitarget kinase inhibitor.
The good of the many versus the good of the individual is the age-old question that faced the FDA’s Vaccines and Related Products Advisory Committee (VRPAC) June 10 as it considered the risk-benefit issues of COVID-19 vaccines in children. Panelist Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, said while he believes a vaccine is needed for children, he wants to know that the safety of the vaccine is greater than the risk of hospitalization for people younger than 18.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Arena, Coordination, Dynacure, Lyra, Moderna, Ocugen, Scynexis, Vertex.
The FDA’s Center for Devices and Radiological Health (CDRH) issued a new document on June 8 responding to the National Institute of Standards and Technology (NIST) call for position papers to fulfill the President’s Executive Order on improving the federal government’s cybersecurity. It details how CDRH is planning to do its part to advance the shared goal within medical devices.
Cymedica Orthopedics Inc. received FDA clearance for its Intellihab system to reduce pain associated with osteoarthritis in the knee. The system uses neuromuscular electrical stimulation to strengthen muscles supporting the knee without requiring typical exercises such as squats that could increase pain and further degrade the joint. Intellihab includes a knee brace that emits the pulses and a smartphone app patients use to track and manage the therapy.
The FDA’s two-day advisory hearing yielded recommendations for risk designation for a number of product types, such as plunger-like joint manipulators, which received a unanimous endorsement for a class III designation. The advisory panel was split on the risks associated with electro-acupuncture stimulators, which the FDA must now decide whether to classify as a class III device, a move that would force a number of existing devices into clinical trials for an expensive and time-consuming PMA application.
Eyeyon Medical Ltd. has won CE mark approval for its flagship product, Endoart, a synthetic implant that replaces the human endothelium, which the body can’t regenerate. Designed to treat chronic corneal edema, it could help to reduce the long wait times for human donor corneas. Approval was based on a first-in-human trials involving 22 patients who received Endoart implants and were followed for 24 months.
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