FDA warning letters to device makers have been conspicuous in their paucity in recent years, but they have been surfacing with greater frequency over the past few months.
The FDA has awarded a breakthrough device designation to a polymer film implant to create an artificial endothelial layer in the eye. Known as Endoart, it is designed to replace a non-functioning endothelium, which is the single layer of cells on the inner surface of the cornea. Without it, excess fluid flows into the cornea and can result in severe vision loss.
Aria CV Inc., which focuses on pulmonary arterial hypertension (PAH), has won a breakthrough device designation from the U.S. FDA for the Aria CV pulmonary hypertension (PH) system. The implanted Aria CV PH system aims to restore the benefits of a healthy, elastic pulmonary artery, which in turn reduces cardiac workload and enhances blood flow.
A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
Aimmune Therapeutics Inc. wasted no time moving ahead after last week’s FDA approval of Palforzia for peanut allergy as the Brisbane, Calif.-based company obtained an exclusive worldwide license to develop and commercialize Xencor Inc.’s humanized monoclonal antibody, XmAb-7195, for treating allergic asthma.
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