Bob Califf, commissioner of the U.S. FDA, has been laser-focused on misinformation recently, and the agency reissued a 2014 draft guidance that describes an enforcement policy about third-party communications about a drug or device. The draft appears to sidestep at least one major problem with the 2014 edition, but seems to suggest that manufacturers should consider addressing misinformation about an entire class of products.
Australia’s Therapeutic Goods Administration (TGA) made significant changes to some of its regulations, including those for software-based medical devices. The TGA said that entities that are switching their products to a higher risk classification can continue to offer them for six months after Nov. 1, 2024, if they have an application on file with the TGA, but only if the sponsor notified the agency of such intent prior to May 25, 2022.
U.K scientists and ethicists have drawn up a code of practice for research in stem cell-derived embryo models, filling a governance gap that has opened up as these organoids have become more sophisticated and increasingly resemble their natural counterparts. “Synthetic” embryos now have the ability to organize into complex structures that approximate aspects of early human development, such as a beating heart, complex neural structures capable of signaling, sensory perception and limb-like structures.
Health ministers from EU member states called for action to “enhance access to innovative medicines” following a Council meeting on June 21, when they agreed to continue work on improving health policy coordination across the bloc. Health must be “kept as a priority” by the new European Commission that is shortly due to start a five-year term, following the June EU elections, ministers said, setting out the key areas where they want the incoming commission to concentrate its efforts.
The pilot version of the U.S. FDA’s advisory program for breakthrough medical device life cycle management was initially limited to cardiovascular devices, but the agency has announced an expansion into other product areas. Going forward, orthopedic, radiological and ophthalmic devices will be eligible for the FDA’s Total Life Cycle Advisory Program, which will aid applicants in obtaining both faster and more trouble-free market access.
Less than a month after the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee handed down a unanimous vote in favor of Eli Lilly and Co.’s Alzheimer’s disease candidate (AD), donanemab, the agency approved the drug as a once-monthly injection for adults with early symptomatic disease. Branded Kisunla, the beta-amyloid antagonist marks the second approved AD drug that has demonstrated in clinical trials an ability to slow cognitive decline, going up against Leqembi (lecanemab) from Biogen Inc. and Eisai Co. Ltd., which won full approval in July 2023, only six months after nabbing an accelerated nod.
Confidence in working with Chinese biopharma companies has dropped by 30% to 50% for U.S.-based life sciences companies, with Chinese contract development and manufacturing organizations the hardest hit, according to a recent LEK survey of global life sciences companies on the impact of the pending U.S. Biosecure Act.
The problems with U.S. Medicare coverage for medical software are well known, but the Medicare Payment Advisory Commission recently indicated that these problems are largely manageable for services delivered via managed care plans.
The U.S. FDA granted Signum Surgical Ltd. de novo marketing clearance for its Biohealx technology as a treatment for anal fistula. Biohealx is a single use, bioabsorbable implant, designed to not only to treat the condition in a minimally invasive procedure but also promote healing, prevent fistula recurrence and protect patient continence.
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