fda
Every record this desk has filed under fda, newest first, each with the number of sources it can still show you.
FDA grants accelerated approval to an immunotherapy for adults with recurrent respiratory papillomatosis, with benefit still to be confirmed
The FDA granted accelerated approval October 30 to Voceryq for adults with recurrent respiratory papillomatosis, a rare airway disease that can require repeated surgery. The agency cited fewer surgical procedures in a small, open-label trial. The manufacturer must run post-approval trials to verify the clinical benefit; the approval announcement does not establish that the treatment cures the disease.
Also filed underrespiratory-diseaseaccelerated-approvalclinical-trialspatient-care
FDA draft guidance would set cadmium action levels for processed baby foods
FDA has opened comments on draft cadmium action levels for certain processed foods intended for children under two. The recommendations range from 10 parts per billion for most fruit, vegetable and mixed foods to 45 parts per billion for dry infant cereals. They are not final or binding. Comments are due December 22 for consideration before FDA starts the final guidance.
Also filed underbaby-foodcadmiumfood-safetydraft-guidancepublic-comments
FDA approves hepatitis B treatment for some adults already taking antiviral medicine
FDA approved Hibsago on October 20 for certain adults with chronic hepatitis B who do not have cirrhosis and meet treatment and laboratory requirements. Across two trials, 24% of treated patients qualified to stop their existing medicine. The injection carries a boxed warning for serious liver reactions and low platelet counts.
Also filed underhealthhepatitis-bdrug-approvalspatient-safety
FDA final guidance explains when prescription-drug apps belong in a medicine's official labeling
FDA released final guidance on October 20 about software disseminated by or on behalf of prescription-drug sponsors, followed by an October 21 Federal Register notice. It addresses app content, prescribing information and submissions for FDA review. The guidance is nonbinding, and the notice permits comments at any time rather than setting a new closing date.
Also filed underhealthdigital-healthprescription-drugslabelingfederal-register
FDA publishes notice of four earlier emergency animal-drug authorizations for New World screwworm
FDA's October 15 notice announces four emergency animal-drug authorizations issued between August 7 and September 3, 2026, for specified uses against New World screwworm. The products cover different animals and prevention or treatment uses. The announcement is not a new finding of a U.S. outbreak, and each authorization has conditions that must be read in its own letter.
Also filed underveterinary-medicineanimal-healthemergency-authorizationpublic-notices
FDA starts a rare-disease framework initiative and schedules an October 28 meeting
FDA announced October 14 that it is beginning work on a rare-disease framework tailored to small patient populations, disease characteristics and the evidence available for a product. An October 28 meeting at its White Oak campus is planned as an early step. The announcement begins a development process; it does not approve a drug or establish a final regulatory framework.
Also filed underrare-diseasedrug-developmentpublic-participationhealth-policy
FDA's final rule, scheduled to publish October 13, permits salt substitutes in 139 food standards, from cheddar to canned corn; using them is optional
The Food and Drug Administration filed a final rule October 9, scheduled to be published October 13, that permits salt substitutes in 139 federal food standards, among them cheddar, bread, canned corn, margarine and mayonnaise. Using one is optional. FDA adds no label requirement and points shoppers who watch potassium to the ingredient list and Nutrition Facts label. The Register's record gives an effective date of December 14; objections to the dairy standards are due November 12.
Also filed underfood-labelingsodiumpotassiumfood-standardsfederal-register
FDA codifies infant oxygen monitor controls covering performance, caregiver understanding and instructions about their limits
An October 9 FDA order puts controls for over-the-counter infant pulse and oxygen monitors into federal regulations. It codifies a classification that applied in November 2023, rather than announcing a new product approval. The controls require testing across expected users and conditions, including skin pigmentation, and instructions that help caregivers interpret readings and understand appropriate actions.
Also filed underhealthinfant-monitorsmedical-devicesconsumer-protectionfederal-register
FDA codifies home-collected STI test controls, including laboratory shipping and warnings about negative results
FDA's October 9 order codifies controls for tests that use specimens collected at home to detect non-viral microorganisms causing sexually transmitted infections. Testing takes place in a clinical laboratory, and the box must make that shipping step clear. The classification dates to November 2023. Required warnings say negative results do not rule out other pathogens and the system does not replace a healthcare visit.
Also filed underhealthsexually-transmitted-infectionshome-testingmedical-devicesfederal-register
An infant monitor can give you a number. That is not a promise to keep a baby safe.
FDA's October 9 order codifies the existing class II classification for infant pulse and oxygen monitors, with special controls. The controls include testing whether caregivers can interpret the output and understand the next steps to take. Read alongside the agency's earlier warning on infant monitors, the distinction is plain: an authorized measurement is not authorization to claim prevention of sudden infant death. The useful question is what the device is allowed to tell you, and what it cannot promise.
Also filed undermedical-devicesinfant-monitorsproduct-claimspublic-record
A cable inside React Health's VOCSN ventilators, machines used in homes as well as hospitals, can work loose after a hard knock such as a drop and make the machine reboot; the FDA's September 23 early alert covers every unit with serial number 112786 or higher, and the company's September 17 letter says to keep backup ventilation ready and run a checkout procedure after any drop.
The Food and Drug Administration issued an early alert on September 23 for React Health's VOCSN ventilators, which are used at home as well as in hospitals and in transport, for patients from children to adults weighing at least 5 kg. A cable inside the machine can come partly or fully unseated, and a hard knock such as a drop can cause it; the ventilator can then reboot and show recurring System Fault 10 alarms. A reboot during use would interrupt ventilation. The alert covers every VOCSN-series machine with serial number 112786 or higher. React Health's September 17 letter to customers says to keep backup ventilation working and ready, keep the machine on a flat, stable surface or in its roll stand or carry bag, run the manual's Checkout Procedure after any drop or impact, and not stop therapy without an alternative and a clinician's instruction. The company says no reboots during therapy have been reported and calls that risk remote; as of August 12, 2026, it had reported no serious injuries or deaths. Questions go to React Health at 844-698-6276.
Also filed undermedical-devicesventilatorshome-carecaregiverspatient-safety
The FDA has put Abiomed's removal of every Automated Impella Controller, the console that runs the Impella heart pump, in its most serious recall class; Abiomed has reported 37 serious injuries and three deaths associated with a failing sensor part, and hospitals may keep using the controllers until that part is replaced.
On September 24 the Food and Drug Administration said it had classified Abiomed's removal of its Automated Impella Controllers, the consoles that run the Impella heart pump, as a Class I recall, the most serious type. A part in the controller's purge pressure sensor assembly, the purge flag, can fail, so the controller stops recognizing the purge disc and raises a 'Purge Disc Disconnected' or 'Purge Disc not Detected' alarm. Clearing it can mean swapping the controller, which can delay the start of support or briefly interrupt it. As of August 17, Abiomed had reported 37 serious injuries and three deaths associated with the issue. Every controller worldwide is in scope, and FDA's three recall database entries together list 10,754 units, 7,005 of them in the United States. Hospitals may keep using them until Abiomed services them, and are told to switch to a backup controller if the alarm will not clear. Abiomed began the recall with letters on August 12. A separate FDA early alert, current as of September 23, lists 237 controller serial numbers needing hardware, firmware or software updates; no serious injuries or deaths were reported for that issue as of September 8.
Also filed undermedical-devicesdevice-recallsheart-pumpabiomedhospitalspatient-safety
A customer found a bag of concentrated potassium chloride inside a wrap labeled as saline, and Otsuka ICU Medical has recalled saline lot 1042188, distributed in the United States from December 30, 2025 to June 22, 2026; it is the third recall this desk found since February 2025 in which an ICU Medical-brand potassium chloride bag sat in a wrap that did not match it.
Otsuka ICU Medical LLC is recalling one lot of 0.9% Sodium Chloride Injection, USP, 100 mL (NDC 0990-7984-23, lot 1042188, expiring 31 October 2027) after a customer found a bag of highly concentrated 10 mEq potassium chloride injection (NDC 0990-7074-26, lot 1035181) inside the saline's overwrap. The lot was manufactured November 13, 2025 and distributed in the United States from December 30, 2025 through June 22, 2026. The company's announcement, dated September 17 and posted by FDA on September 21, says inadvertent injection of concentrated potassium chloride can cause harm up to death from cardiac arrest, and that the company has received no reports of adverse events. Customers, including distributors, are asked to check their inventory, quarantine the lot and stop using it. This desk found two earlier recalls, in February and October 2025, in which ICU Medical-brand potassium chloride bags sat in wraps that did not match them; FDA classified both Class I, its most serious category. FDA's enforcement data, last updated September 16, held no classification for the new recall when this desk looked.
Also filed underdrug-recallpatient-safetyhospitalsiv-fluidsmedication-errors
FDA approves the first treatment for Sanfilippo syndrome type A. The evidence used a historical comparison group.
Fayuvi's September 17 approval gives families a new treatment option. The study design and safety warnings matter alongside that milestone.
Also filed undergene-therapypublic-health
FDA opened applications for a pilot meant to shorten the road to a first-in-human drug trial. Eight to ten pairs get in, the window closes October 30, and the agency keeps every power it had.
On September 15 the FDA announced the final design of its Expedited Investigational New Drug Pilot and began accepting applications. Drug sponsors apply paired with a qualified research institution; the FDA will review and accept individual components of an IND application on a rolling basis during the pre-IND phase rather than waiting for the whole package, with the aim of finding problems early enough to avoid a clinical hold during the 30-day IND period. The agency says first-in-human trials 'may take up to two years to complete in the United States' and are finished faster in China and Australia. Applications close October 30, 2026; the FDA expects 8-10 sponsor-institution pairs in the first cohort, and states it retains full regulatory authority throughout, including whether a trial may proceed.
Also filed underclinical-trialsdrug-developmentdeadlinehealth
Four things to check at home this week: two sunscreen ingredients FDA just ruled out, a 2.3-million-bottle candy recall, fire-spray canisters that can rupture, and a cheese with undeclared egg.
On September 11 the FDA published a final order removing PABA and trolamine salicylate as sunscreen active ingredients, finding that a sunscreen containing either is not generally recognized as safe and effective. The day before, the Consumer Product Safety Commission announced two recalls a household can check in seconds: about 2.3 million Ricky Joy Sour Crush rolling liquid candy bottles, whose rolling ball can detach and choke a child, and about 31,000 Hero Fire Spray canisters, which can deteriorate and rupture — the firm has nine reports of canisters exploding or deteriorating in storage. And Whole Foods Market is recalling Cabricharme cheese sold at 18 stores because it contains an egg protein not declared on the label. What each notice asks you to look for, and what none of them says.
Also filed undercpscrecallsconsumer-safetysunscreenfood-safetyallergens
Two recalls this week come down to a number you can check at home: one UPC on a bag of broccoli sprouts, and six lot codes on wellness vials.
A Salmonella outbreak linked to sprouts has made 22 people sick in Idaho, Montana, Utah and Washington, two of them hospitalized, and Evergreen Fresh Sprouts, LLC is recalling 215 cases of broccoli sprouts carrying UPC 8 38796 00105 1 and five Use By dates from 9/07/26 to 9/16/26. Separately, Houston's Centric Compounding is recalling six lots of injectable Glutathione, Myer’s Cocktail and Tri-Immune Boost vials — shipped nationwide, including straight to patients' homes — after finding they were compounded with a Glutathione ingredient containing elevated endotoxin levels; the company has received nine reports of reactions. Both notices are company announcements posted by the FDA, and both ask for the same thing: match the code, and throw it out.
Also filed underrecallsfood-safetysalmonellacompoundingpublic-health
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