The FDA announced it will require changes to the boxed warnings of chimeric antigen receptor T-cell therapies for cancers to highlight the risk of secondary blood cancer among users. The agency noted that patients and clinical trial participants receiving CAR T-cell therapies should receive lifelong monitoring for secondary cancers, and the drug manufacturer should be informed if new malignancies happen.

The trade association Council for Responsible Nutrition has released two sets of voluntary guidelines, with one for "labeling of gummy dietary supplements" and the other for "formulation, labeling and packaging of melatonin-containing dietary supplements." The guidelines aim to address the rise in cases of accidental melatonin ingestion by children.

BiVictriX Therapeutics' novel antibody-drug conjugate BVX001 has received orphan drug designation from the FDA as a potential treatment for acute myeloid leukemia.

The FDA said shortages of most dose sizes of Eli Lilly's diabetes medication Mounjaro and weight loss drug Zepbound are likely to continue through the second quarter of 2024, mainly because supply is not keeping up with high demand. Officials originally said the shortages were expected to run through this month. Only the 2.5 mg dose of each drug remains unaffected by the supply issue.

Alvotech and Teva Pharmaceuticals' Selarsdi, or ustekinumab-aekn, a biosimilar of Stelara, was approved by the FDA for the treatment of adults and children ages 6 and older with active psoriatic arthritis and moderate to severe plaque psoriasis. The drug is expected to become available in February.

The FDA has released the Chemicals List for Analytical Performance, a chemical dataset that is intended to aid medical device sponsors in the biocompatibility testing and review processes. "A central tenet of the [Center for Devices and Radiological Health] biocompatibility evaluation is for sponsors to have the option, for some biocompatibility endpoints, to undertake extraction studies to identify and quantify chemicals released from a device and then to perform a toxicological risk assessment (TRA) to determine if the chemicals pose safety issues in the use of the device," said CDRH Director Jeff Shuren.

The FDA announced recalls of two implantable blood-pumping devices for people with end-stage heart failure, Thoratec's HeartMate II and HeartMate 3, as the devices have been linked to 14 deaths and at least 273 cases of injury. The products are not being taken off the market, as there are few other options for these patients.

The CDC has issued an alert warning consumers that Trader Joe's Infinite Herbs fresh organic basil has been linked to at least 12 salmonella cases. The reported cases were in Wisconsin, New Jersey, Missouri, Rhode Island, Florida, Georgia and Minnesota.

Minnesota House lawmakers have voted in favor of a bill that would allow the Office of Cannabis Management to issue preapproved operating licenses for cannabis dispensaries. The bill would also authorize the office to oversee enforcement of medical marijuana and hemp-derived edible products.

This webinar will explore three key design factors for user-centric medical devices -- user, use environment, and intended use -- companies should consider to manufacture devices that are easier for patients and caregivers to understand and use. Panelists will also provide guidance on evaluating these factors in practice, reevaluating when one or more factors change, and incorporating post-market data to further improve designs. Register now.

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