The FDA’s premarket review mechanisms for class II medical devices may strike some as little more than so much regulatory esoterica, and several courts have ruled that information about the 510(k) process is inadmissible during jury trials due to the possibility of sowing confusion among jurors. An appellate court in New Jersey has ruled that such an exclusion of evidence is prejudicial in a case involving surgical mesh manufactured by two device companies, however, opening a larger debate about the propriety of such exclusions in product liability litigation for medical devices.
The Medical Device Innovation Consortium (MDIC) has been hard at work on the Make CAPA Cool program in an effort to beef up device makers’ corrective and preventive action (CAPA) programs. Kathryn Merrill, regulatory program director for Dublin-based Medtronic plc, said on an April 26 webinar that participants in the program have shaved CAPA times from 381 days to as few as 63 days, an improvement that industry hopes will ward off warning letters and product quality issues.
As part of a U.S. FDA evaluation of confirmatory trials for anti-PD-1/PD-L1 antibodies, the agency’s Oncologic Drugs Advisory Committee (ODAC) is being asked this week to consider whether three blockbuster biologics should continue to be available for certain cancer indications for which they received accelerated approval. At question is whether the data from the confirmatory trials for the Roche Group’s Tecentriq (atezolizumab), Merck & Co. Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Co.’s Opdivo (nivolumab) has proved sufficient benefit in particular indications and, if not, whether alternative or ongoing trials could do so.
The Supreme Court heard the case of Minerva Surgical Inc. v. Hologic Inc., which takes up the question of assignor estoppel for patents, but the discussions that peppered the April 21 hearing lent little clarity as to how the nine justices will decide the case.
The CDC’s Advisory Committee on Immunization Practices again took up the matter of risk vs. benefit with the COVID-19 vaccine made by Johnson & Johnson, and proved significantly less skeptical at its second meeting. The FDA and CDC swiftly determined that the recommended pause should be lifted and use of the vaccine should resume.
As of 2020, the NIH had identified 507 grant recipients who potentially had undisclosed conflicts of interest, with many of those conflicts involving affiliations with foreign governments that may expect the scientists to share or steal NIH-funded research.
HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review.
The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.
A team led by researchers at the Institute of Bioelectronic Medicine at The Feinstein Institutes for Medical Research, the research division of New York’s Northwell Health, developed a long-term implant model for vagus nerve stimulation (VNS) in mice that enables study of bioelectronics in chronic disease. The research was published in Elife, with a full description of the surgical technique and methods for calibrating the stimulation dose to enable other labs to use the methods to advance bioelectronic medicine.
Safeguard Medical LLC further consolidated its position in the first responder market with the acquisition of H&H Medical Corp. Williamsburg, Va.-based H&H produces military-grade trauma response products for field medics and emergency responders. "Our mission at Safeguard Medical is to equip and enable responders at every skill level to preserve life in any environment. The acquisition of H&H adds another trusted brand to our market-leading portfolio and expands our ability to partner with life-saving responders around the world," said Adam Johnson, Safeguard Medical’s CEO.