Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Acepodia, BMS, Eli Lilly, Hepion, Moderna.
The U.S. FDA had previously recommended that power morcellation be conducted only with tissue containment systems and has released a draft guidance for non-clinical testing for these containment systems. While the demands for non-clinical testing are rigorous, the draft also said that clinical testing is likely to be required as well, raising the question of why the agency failed to include clinical testing recommendations in the same draft guidance.
The U.S. FDA may be the most advanced regulatory agency when it comes to artificial intelligence (AI) and machine learning (ML), but developers of these products still have little in the way of FDA guidance to work with in many instances. Cassie Scherer of Dublin-based Medtronic plc, told attendees at this year’s Food and Drug Law Institute annual conference that they should have a product change control protocol ready to go despite the absence of FDA guidance on the subject, an effort that will increase time to market but pay eventually big dividends.
The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers to crack down on some of those schemes.
Instead of “Mother, may I” for COVID-19 vaccines for children 6 months through 5 years of age, the U.S. CDC is saying the correct response is “I should.” That was the recommendation June 18 from the CDC’s Advisory Committee on Immunization Practices. CDC Director Rochelle Walensky wasted no time in endorsing the recommendation, which came just a day after the FDA authorized the vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE for babies, toddlers and preschoolers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biontech, Cytokinetics, Excellthera, Kazia, LG Chem, Moderna, Mydecine, Novartis, Obseva, Pfizer, Rhythm, Sierra, Theramex.
Los Angeles-based cancer diagnostics company Nonagen Bioscience Corp. obtained CE marking for its Oncuria immunoassay for bladder cancer. The multiplex urine test is designed to detect the concentration of 10 proteins that are associated with bladder cancer in urine samples. Clinical studies found the test has a 93% sensitivity and 93% specificity for detecting bladder cancer. The test is also designed to predict whether people are more likely to respond to bacillus Calmette-Guérin (BCG) therapy, a first-line treatment for bladder cancer.
Just three months after raising $10 million from its IPO on the Paris Euronext Growth market, SMAIO SA (Software Machines and Adaptive Implants in Orthopedics) obtained U.S. FDA 510(k) clearance for its Balance Analyzer 3D surgery planning software and for its patient-specific union rods. This spinal realignment planning software uses medical imaging of the patient’s spine in an upright static position.
The U.S. FDA is among the regulators that are taking account of the views of patients in medical device development and regulation, but artificial intelligence (AI) and machine learning (ML) are terra incognita for many, if not most patients. Rebekah Angove, vice president for patient experience and program evaluation at the Patient Insight Institute, told BioWorld that while some patients clearly want to know more about AI and ML, it is also clear that more than a certain amount of detail is more of a distraction than a help for most patients.
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