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Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a list of bulk drugs for which there is a clinical need under section 503B of the FD&C Act and notices of advisory committee meetings for oncologic drugs, endocrinologic and metabolic drugs and vaccines and related biological products. Read More
The FDA has announced a new testing tool, and approved several systems for cryoablation, donor lung preservation and cervical disc replacement. Read More
The device’s benefit was quite modest, on the order of what one might expect with the addition of one extra antihypertensive medication, the panel said. Read More
This European Edition of Quick Notes includes a Swissmedic study of drug approval times, $16 million awarded by UK Innovate, an announcement by Roche of phase 3 anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) preliminary results and an Access to Medicine Foundation report on antimicrobial resistance and responsible manufacturing. Read More
Draeger Medical has voluntarily recalled its Carina Sub-Acute Care ventilators — which the FDA has deemed a class I recall — to address the potential presence of contaminants in the device’s airpath. Read More
Although unanimously endorsing the safety of Medtronic’s Symplicity Spyral Multi-electrode Renal Denervation system, members of the FDA’s Circulatory System Devices Panel were split on both the efficacy and risk/benefit balance of the ultrasound-powered device, intended to treat hypertension by ablating sympathetic nerves in the renal arteries. Read More
Philips says it has no reports of harm from this issue and has provided instructions to follow until the company can inspect the device, which may continue to be used. Read More
Apellis Pharmaceuticals’ safety probe into reports of retinal vasculitis linked to its eye drug-device combo Syfovre (pegcetacoplan) has discovered that the culprit is likely the company’s injection kits, not the therapy itself. Read More
Intarcia Therapeutics will continue its seven-year quest for FDA approval of its drug-device diabetes treatment with an alternative form of hearing — a public hearing before an advisory committee on Sept. 21to discuss CDER’s refusal to approve the product. Read More
Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and webinars from FDAnews, a WCG company on medical device risk management tools and calculating sample sizes for verification and validation activities. Read More
An FDA advisory panel has endorsed ReCor Medical’s novel ultrasound renal denervation system, agreeing unanimously that it’s safe for use in adults with uncontrolled or inadequately controlled hypertension, although the 12 voting members disagreed about how effective the ReCor Paradise system will be in the long run. Read More