For how we live.
A final FDA guidance treats the on-screen output of software sent with a prescription drug as a type of drug labelling, and says how the prescribing information should describe it and when sponsors submit it for review.
A final FDA guidance sets out the safety information companies should provide when notifying the agency of a new dietary ingredient, replacing the old 'comprehensive safety profile' with a single 'safety narrative.'
A proposed rule would cut the Part D generic copay from $1 to $0 for the lowest-income dual eligibles in 2028, tighten Medicare Advantage directory accuracy, and add PBM transparency rules. Comments close 15 December.
The agency authorised emergency use of four veterinary products to prevent or treat New World screwworm infestations, acting on a 2025 declaration that the parasite poses a potential public-health emergency.
The Fit-for-Purpose Rare Disease Framework Initiative launches with a 28 October public meeting and a request for comments. The FDA wants to tailor its review to very small patient populations.
A new 30-day order under the Public Health Service Act continues suspending the entry of certain travellers recently in DR Congo, Uganda or South Sudan. It runs through 10 November; comments close 30 October.
A 9 October labelling supplement folds results from two post-marketing rheumatoid-arthritis safety studies into the JAK inhibitor baricitinib's boxed warning, and revises its infection and cardiovascular sections.
A final rule amends 80 FDA standards of identity so makers can replace some or all added salt with substitutes, part of a push to cut sodium tied to high blood pressure. It takes effect 14 December 2026.
A final question-and-answer guidance tells biosimilar makers what data to file when they change how an approved product is made, fulfilling a 2022 user-fee commitment. It was issued on 13 October 2026.
A proposed rule would push several compliance dates under the 2024 trichloroethylene risk rule to 31 December 2027, giving processors and refrigerant makers more time to drop the solvent. Comments close 13 November.
A final order published 9 October classifies the over-the-counter infant pulse rate and oxygen saturation monitor as class II, with special controls built around the risk that it fails to detect a pulse.
A final order published 9 October classifies systems that let people collect their own specimens for non-viral STI testing as class II, moving them out of the automatic class III that demands premarket approval.
A draft guidance published 9 October would spare mid-sized retail food establishments and restaurants from all Food Traceability Rule requirements. Comments close 23 November; a public meeting follows on 6 November.
A final order codifies Class II status for high-throughput DNA sequencing systems that detect germline mutations in cancer genes, built on Invitae's panel. It becomes a predicate other makers can clear against.
A notice sets out how the agency intends to designate every US area for the 9.0 microgram 2024 fine-particle standard. Comments close 5 November; a court has ordered final designations by 6 February 2027.
A CMS and CDC proposed rule would codify pandemic-era remote review of digital lab data, allow digital images in gynaecologic cytology proficiency testing, and ease 2024 staffing rules. Comments close 7 December.
A tri-agency final rule, effective 7 December, overhauls the machine-readable price files insurers must post and requires cost estimates by phone. The changes apply to plan years from 1 January 2027.
A final order codifies a new Class II category for systems that destroy soft tissue with sound rather than heat, built on HistoSonics Edison System. It becomes a predicate other makers can clear against.
A draft NIH policy out for comment would require researchers to share plain-language summary results with clinical research participants for all NIH-supported studies, unless justifiably not appropriate.
HRSA has finalised eligibility guidelines for its Living Organ Donation Reimbursement Program under the HOLD Act, which bars considering the recipient's income. Eligibility now turns on the donor's own income.
An FDA advisory committee will meet on 30 October to review Sydnexis's atropine sulfate 0.01% eye drops, proposed to slow myopia progression in children aged 3 and older. The public docket closes 29 October.
The final FY2027 rule lifts the federal per diem base rate to $912.40 and the electroconvulsive-therapy rate to $688.59 from 1 October, adds a standardised patient-assessment tool, and drops two quality measures.
An order effective 25 September lets manufacturers use inactive baker's yeast to add vitamin D2 to cereals, grain products, milk and milk products, at the same limits already set for vitamin D2 mushroom powder.
A final order published 17 September denies a petition that sought to exempt four classes of computer-aided detection, diagnosis and triage devices from 510(k) clearance. Makers must keep filing before they market.
A mandatory CMS payment model finalised 2 October recalculates inflation rebates for certain physician-administered drugs against an international benchmark, and can cut a patient's coinsurance to 10%.
A new history of Norway's 1975 ban — one of the WHO's three 'best buys' against alcohol harm — traces how it survived courts, alcohol-free beer and social media, and why pressure to modernise it worries defenders.
The FDA logged the recall of 2,718 Medline convenience kits on 23 September: sterile applicators in some lots could grow the mould Aspergillus penicillioides, and contaminated skin-prep risks infection or sepsis.
A final action moves the Serious-area deadline for the Los Angeles-South Coast fine-particle area from December 2025 to December 2030, after California showed on-time attainment was impracticable. Effective 2 November.
A final order classifies the flushing and storage solution for vascular autografts as Class II with special controls, codifying a 2023 De Novo decision on Marizyme's DuraGraft and setting the bar for future copies.
The Class I recall covers 625,500 prefilled syringes. Cartons labelled morphine sulfate 2 mg/mL hold a Dilaudid (hydromorphone) syringe of 0.5 mg/0.5 mL instead — the wrong opioid at the wrong dose.
The FDA classified the nationwide recall Class I, its most serious tier. About 31,935 multi-dose vials are affected, with particulate identified as nylon, glass and other materials, plus broken and leaking units.
A new draft guidance sets out the agency's current thinking on the non-clinical and clinical data it expects in premarket submissions for robotically-assisted surgical devices. Comments are due 24 November.
A January 2025 draft guidance lays out the documentation the agency expects across an AI device's whole life, including bias checks across demographic groups and postmarket monitoring. It is not yet binding.
An interim final rule lets HHS freeze federal-marketplace registration for agents and brokers without a current plan-year agreement. CMS imposed the pause immediately; it runs until 1 February 2027.
A direct final rule swaps 'animal' for 'nonclinical' across five parts of FDA's drug regulations. It adds no requirements, but signals a shift the agency began with monoclonal antibodies.
Since 2024 the FDA has cleared over-the-counter CGMs for people who don't use insulin. The first independent accuracy check in adults without diabetes finds the sensors track the trend but miss the exact number.
'Natural', 'clean' and 'organic' have no agreed regulatory meaning on a cosmetic label, and some plant-derived and fragrance ingredients are among the most common triggers of allergic skin reactions.
A federal rule now requires certified electronic health records to publish a standard set of facts about each predictive algorithm they ship, including how it was validated and whether it was tested for fairness.
A dormant breach-notification rule became an enforcement tool in 2023, when the FTC fined GoodRx and BetterHelp for sharing users' health data with ad platforms. A 2024 rule change locked apps into its reach.
Under Article 6, AI that is or sits inside a device already needing an independent safety check counts as high-risk. A 70-study review finds the trouble is overlap with existing device law.
CMS took comment through 18 September 2026 on draft rules for how manufacturers must deliver negotiated drug prices in 2028. The mechanism is a refund owed within 14 days, not a lower shelf price.
Abilify MyCite embeds a sensor in an antipsychotic tablet to log each dose to an app. Nearly a decade on, its own FDA label still says it has not been shown to improve whether patients take their medicine.
The agency is repealing the carbon-capture-based standards at the heart of the 2024 rule, saying compliance-cost savings outweigh the emission cuts. It takes effect on 16 November 2026.
The US banned Red No. 3 in 2025 on a rat-specific cancer finding, not human data. The separate question — whether dyes affect children's behaviour — has better, and more unsettling, evidence.
Rings and watches sold online promise needle-free glucose readings. The FDA says do not use any of them, and even research-grade non-invasive sensors miss the mark by about a fifth.
The RAPID pathway would issue a proposed national coverage decision the day a device clears the FDA, cutting a process that normally runs 9 to 12 months. The trade-off is evidence.
A controlled study tied Scotland's minimum unit price to a 13.4% fall in deaths wholly caused by alcohol, largest in the most deprived areas. The effect on hospital admissions was smaller and not significant.
A final order files AI tools that flag possible cardiovascular disease as class II with special controls, letting similar triage software clear via 510(k). The controls require real-world, subgroup-tested validation.
The oral decongestant in most cold and sinus tablets — phenylephrine — works no better than placebo, US regulators now say. Saline and short-term sprays do more.
A pandemic waiver letting clinicians prescribe stimulants and other controlled medicines without an in-person visit has been extended a fourth time, to end-2026, with the permanent framework still a proposal.
Medicare paid over $500 million for remote monitoring in 2024, but a watchdog found 43% of patients didn't get the full service — and rigorous evidence that it improves outcomes remains limited.
Reviews find portals may improve awareness and the patient–doctor relationship, with unclear effect on efficiency. Under new US rules, patients now see 40% of results before their clinician does.
A 2025 rule created billing codes for FDA-cleared mental-health software. The 2026 rule adds short-episode remote-monitoring codes but declines to widen the digital-therapy benefit.
A predetermined change control plan is the FDA's answer to a model that keeps learning: pre-approve a bounded set of future changes, and the manufacturer can ship them without returning for a fresh review.
23andMe's cleared BRCA report reads 3 of more than 1,000 mutations, so a negative result is not the all-clear it looks like — and the firm's bankruptcy has put customers' genetic data in play.
A review of 23 women's health apps found 87% shared user data with outside firms. The main US rule that covers them orders breach disclosure — it does not stop the sharing.
The agency revoked Orange B and proposed dropping Citrus Red No. 2 because neither has been used in decades. It said the safety of synthetic colours is outside the scope of these orders.
Europe cut its safe intake for BPA by orders of magnitude and banned it in food packaging. US regulators disagree, and the substitutes are less studied.
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.
Most wellness apps make no disease claim and face no federal review. Into that gap, US states are writing their own AI-in-mental-health laws — four already diverge, leaving users unevenly protected.
The final rule raises operating payment rates 2.4% and directs about $2.9 billion more to acute-care hospitals in the year from 1 October 2026. Hospital groups called the increase too low.
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.
The dye is being pulled under a 1958 law that bans any additive found to cause cancer in animals, at any dose. FDA's own review calls the rat finding of limited relevance to people.
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.
An audit of 17 manufacturers' privacy policies found transparency the weakest area, with wide variation between brands. The data these devices generate largely falls outside HIPAA and GDPR's clinical protections.
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.
reSET, Somryst and EndeavorRx cleared a real regulatory bar, on real trial data. The pivotal ADHD game moved an attention score by 0.88 of a point. Clearance is not the obstacle the category keeps hitting — payment is.
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.
The 2024 amendments to the International Health Regulations took effect in September 2025, adding a 'pandemic emergency' tier. The United States formally rejected them.
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.
The proposed Nutrition Info box would rate saturated fat, sodium and added sugars on the front of most packaged foods. The strongest real-world evidence is for blunter warning labels.
Reported health-data breaches rose 100% from 2018 to 2023 and the people affected by them 950%. A federal proposal would drop the rule's 'addressable' loophole and require encryption, multi-factor login and more.