Why it matters: The guidance shows the agency’s interest in using accelerated pathways for regenerative therapies, similar to what’s in place for “breakthrough therapies” used to treat serious conditions.

State of play: Congress in 2022 required the FDA to produce the guidance as lawmakers renewed the prescription drug user fee program.

• Drug developers could opt for single-arm trials that use participants as their own control, externally controlled trials that compare patient data to real-world data from people who didn’t receive the new treatment, or test a product concurrently on multiple conditions.

The intrigue: The approach is in contrast to Kennedy’s push for more placebo-controlled studies on vaccines.

The agency also put out guidance on faster reviews for regenerative therapies.

• This largely reiterates 2019 draft guidance but includes more examples of clinical evidence that FDA would consider sufficient to show that a product could address unmet medical needs, Endpoints News reported.

Reality check: The guidance is good news for companies in the cell and gene therapy space, but it’s not clear if the FDA can actually support accelerated development, since there are already delays in the agency’s interactions with companies applying for approvals, Raymond James analyst Chris Meekins wrote in an investor note.

Pentagon still backs mRNA projects

Illustration: Lindsey Bailey/Axios

The Pentagon still is funding research into mRNA vaccines despite Kennedy’s recent pullback of federal funding for the technology behind COVID shots, Nature reports. Why it matters: The continued investment reflects the military’s belief that mRNA is critical to defending troops against deadly pathogens. Catch up quick: In August, Kennedy said the government would halt $500 million in funding for new mRNA vaccines in order to focus on “safer, broader vaccine platforms.” Researchers decried the move, saying the loss of federal support could not only threaten vaccines but also slow research into the prevention of cancer, HIV and other chronic diseases. Driving the news: mRNA projects still receiving federal support include a vaccine against a serious tick-borne disease known as Crimean-Congo hemorrhagic fever that kills up to 40% of those infected, Nature reported. Another project, led by Moderna, is targeting the Marburg virus. In some cases, projects that were jointly funded by the Pentagon and the Biomedical Advanced Research and Development Authority saw only the BARDA side of their funding dry up. An HHS spokesperson told Nature “BARDA is prioritizing evidence-based, ethically grounded solutions.” from STAT: artificial intelligence Proving the potential of AI screenings Artificial intelligence may help radiologists spot disease, but throwing the technology at millions of CT scans or mammograms is not without risks to patients and may drive up costs without showing much benefit. Katie Palmer reports on two efforts to prove out the potential: A large randomized controlled trial will explore the value of AI-aided mammography in screening for breast cancer. The technology is already widely used in the U.S., but the best evidence that it’s useful comes from Europe. The $16 million trial is funded by the Patient-Centered Outcomes Research Institute. Read more on what researchers may find here. Next month, NYU Langone Health will begin checking bone density in CT scans of people over 65 for osteoporosis, a condition that often goes undetected until someone breaks a bone. The health system may expand the work if it’s proven to help. This kind of opportunistic screening, which repurposes otherwise acquired scans, could be used to identify many treatable conditions. Katie’s interview is worth a read.