For how we live.
A section 564 declaration, prompted by a July determination from the Secretary of War, opens the door to authorising unapproved drugs for acute pain in combat and CBRN casualties.
The patented method uses mifepristone for hypercortisolism-related insulin resistance, with dosing capped to avoid over-activating the stress-hormone axis. The public can object before the deal closes.
A draft replacing a 2003 document would extend hepatic-impairment dosing studies to biologic drugs and to drug effects, not just blood levels. It is open for comment before the agency finalises it.
The 2024 US drinking water limits are the reference point for almost every PFAS conversation. Four of the six regulated substances are now the subject of a proposed rescission.
A new discussion paper proposes a two-axis risk framework and a physician-training analogy for evaluating generative AI devices. It is not a rule, and the agency is asking what one should look like.
US government metrologists sent one homogenised faecal standard to seven consumer testing services. Species counts came back ranging from 20 to 1,701 for the same material.
In February, FDA said it intended to act against compounded GLP-1 supply without saying how. The answer arrived in May: exclude semaglutide, tirzepatide and liraglutide from the list.
A comparison of 2020–2025 approvals finds 94 novel oncology drugs from the NMPA against 87 from the FDA, with China's volume overtaking from 2023. The speed and first-in-class figures run the other way.
Two 2026 reviews make the case that human-derived models can replace animal testing. A third paper argues the field is checking the biology and the algorithm separately, and calling that assurance.
Bemotrizinol, a UV filter available in Europe and elsewhere since the early 2000s, cleared US regulatory review this month — more than a decade after a manufacturer first flagged it to the FDA.
A new structured dataset finally makes the approvals countable. Two trials published weeks apart show why counting them says little: 0.86 fewer migraine days in one, a 20-point symptom shift in the other.
A Milbank Quarterly analysis argues wellness companies use the political strategies of harmful commodities industries. A separate review puts the downstream cost of low-value wellness testing above $100 billion a year.
A new audit of China's regulatory record finds a market concentrated in radiology, dominated by deep learning, and clustered in four cities. It also finds the approval curve flattening.
The draft Plausible Mechanism Framework would let a well-supported mechanism of action carry weight where patient populations are too small for randomisation. It is open for comment for 60 days.
Revised guidance reverses the 2022 position that a single recommendation made software a device. The agency's own criterion — that a clinician can independently review the basis — now carries the weight.
The FDA's revised general wellness policy lets non-invasive devices infer blood pressure, glucose and other physiologic parameters. The regulated line is no longer the measurement — it is the sentence next to it.
A study in this month's JAMA Internal Medicine mapped the rules governing IV hydration spas in every state, read 255 of their websites, and phoned them. Two of the websites cited a source.
A systematic review of every AI device authorised from 1995 to June 2024 found 97% cleared through the 510(k) pathway, which does not require independent clinical data on performance or safety.
Across 40 trials, self-guided apps moved panic severity modestly and barely touched fear-related cognitions. Clinician-guided versions moved both — which complicates the scalability pitch.
A census of 691 AI-enabled devices cleared through 2023 found demographic data missing almost everywhere, three summaries reporting patient outcomes, and 113 recalls driven mostly by software.
Forzinity was approved under accelerated approval to improve muscle strength in patients weighing at least 30 kg. The confirmatory trial is not due to report until 2030.
Seven of those nine were denosumab. The committee's September opinions also covered an RSV antibody for infants, a first EU treatment for IgG4-related disease, and four withdrawn applications.
Two BMJ reviews found high-risk usability problems in 18 of 30 tests, and use judged contrary to evidence-based guidance for 11 of the 19 conditions covered.