The FDA’s Sept. 5, 2024, draft guidance for the use of patient preference information (PPI) over the total product life cycle represents a new set of requirements for device makers when obtaining such information. Going forward, device makers may be required to provide more detail about patient heterogeneity, including when the benefit-risk calculation varies by subpopulation.

The U.S. FDA posted a series of de novo decisions Sept. 9, including a digital diagnostic for chronic kidney disease progression by Renalytix AI Inc., of New York, and a digital therapy device for management of fibromyalgia symptoms by Swing Therapeutics Inc., of San Francisco.

The U.S. FDA’s final guidance for device remanufacturing was the result of a nearly decade-long policy examination, and the agency’s Sept. 10 webinar highlighted a few key questions. The FDA’s Angela Krueger said the agency “always encourages transparency” on the part of manufacturers to ensure device safety and performance but said the FDA does not endorse disclosure of trade secrets in providing information on device servicing.

With antimicrobial resistance growing to many first-line antibiotics, a key concern in the U.S. FDA’s approving an oral penem like Iterum Therapeutics International Ltd.’s tablet combining sulopenem etzadroxil and probenecid is that it could become a first-line, go-to drug in treating uncomplicated urinary tract infections and, possibly, more serious infections off-label.

Femasys Inc. checked off a box on the way to launch of its Fembloc non-surgical birth control method with U.S. FDA clearance of Femchec. An enhanced version of the Femvue product used to diagnose fallopian tube abnormalities, Femchec enables confirmation of successful blockage of the fallopian tubes to prevent pregnancy without use of radiation.

With full approval from the U.S. FDA in hand for Travere Therapeutics Inc.’s Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression, eyes turned to future prospects as well as how a revised risk evaluation and mitigation strategies (REMS) program might shake out. During a conference call hosted by Travere, Leerink analyst Joseph Schwartz wanted to know what changes might be made, and if the regulator’s decision might “actually be an entire removal” of the REMS.

The FDA reported several class I recalls in the first week of September 2024, a list that includes products such as Medtronic plc’s McGrath line of laryngoscopes, some of which should be jettisoned.

Medigene AG has obtained FDA clearance of its IND application for lead program MDG-1015 for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma.