PRAC outputs and EU signals, DHPCs, referrals and shortages, MHRA Drug Safety Update, FDA MedWatch and recalls, and national agency safety news, updated every day from the official sources.
The EMA's PRAC has released the final translations of product information text for phenobarbital, linked to a targeted signal management procedure.
EMA's veterinary signal management page sets out marketing authorisation holder duties, revised templates and the closed targeted review of phenobarbital products, which recommended product information changes for dogs.
EMA's safety committee has opened an Article 31 review of all injectable iron products, assessing hypophosphataemia, osteomalacia and whether current risk-minimisation measures work.
EMA's safety committee began a referral on flupentixol/melitracen over serious neurological and psychiatric effects, and started a signal assessment of allergic reactions to human normal immunoglobulins.
Greece's EOF reports that the EMA safety committee is examining batch-specific allergic reactions with immunoglobulin products and has opened a separate review of Deanxit.
The EMA's safety committee will weigh the benefits and risks of the flupentixol/melitracen combination after Belgium raised concerns about severe, long-lasting and possibly irreversible side effects.
AIFA says the EMA safety committee opened a review of hypersensitivity reports linked to immunoglobulin batches and a separate review of Deanxit over serious neurological and psychiatric effects.
EMA's safety committee opened a referral on flupentixol/melitracen and a review of hypersensitivity clusters across all human normal immunoglobulin medicines at its October meeting.
AIFA says the EMA safety committee started an assessment of hypersensitivity reports linked to specific normal human immunoglobulin batches and a review of Deanxit at its October meeting.
EMA's safety committee will examine all normal human immunoglobulin products, whatever the route of administration, after more hypersensitivity reports linked to specific batches, according to ŠÚKL.
The UK regulator proposes more frequent ECG and electrolyte checks for givinostat, with implementation subject to an ongoing independent review; no deaths have been reported in the UK.
The UK regulator's new corporate plan sets out how patients, carers and the public will be involved in its decisions, building on the 2021-2025 strategy.
The agency has widened its 2026 essay competition to pharmacy students and is urging Yellow Card reports on medicines and devices, with low reporting rates for AI-enabled devices flagged.
The MHRA has published its October 2026 Safety Roundup, a periodic digest of the latest safety advice for users of medicines and medical devices. The source text gives no detail on individual items, so QA/PV teams should review the full publication for any product-specific safety communications that affect their portfolio.
The UK regulator's eleventh annual campaign runs from 2 to 8 November 2026, urging suspected side effect and device incident reporting, alongside NHS login integration and a progressive web app.
Medline has updated guidance on continued use and remedies for all its branded beds and accessories, recalled over fire and entrapment risks linked to seven deaths and 35 serious injuries.
The US antitrust agency says combining the two largest distributors to veterinary clinics would raise prices and erode service quality across animal health supply.
FDA analysis found the male sexual enhancement product, sold online and via eBay since at least October 2021, contains undeclared sildenafil and acetaminophen; no adverse events have been reported.
The US agency is prolonging, with modifications, its moratoria on new hospice and home health agency enrolment by six months, citing fraud, waste and abuse.
Too little bonding solvent in manufacture may let soft connectors separate from the tubing, risking loss of ventilation; Intersurgical has told US customers to stop using and quarantine 12 affected product codes.
Teleflex subsidiary Arrow International has told customers to quarantine guidewires and PICC or JACC catheters whose hydrophilic coating may detach and release particles into the bloodstream.
Arizona, Florida, Nebraska, Ohio and Wisconsin become co-plaintiffs in an amended complaint alleging deceptive health-data sharing and unfair billing and cancellation practices.
The US regulator is requiring application holders for every GLP-1 RA to add a Warnings and Precautions entry on a potential increased risk of the rare optic nerve condition NAION.
Spain's regulator reports no legislative changes in July–September 2026, but lists a UDI position paper, an IVD classification guidance update and several patient-safety notes.
Cases in parts of Aragón and Palencia province may signal changing epidemiology; AEMPS and PRAN point to topical antiseptics and microbiological testing while the national antimicrobial guide is revised.
AEMPS's CODEM-VET issued favourable opinions on seven decentralised-procedure applications at its 11 November meeting; formal authorisation decisions remain pending.
The Dutch inspectorate has published a manufacturer warning saying unintended touch signals at the LEONI 4 screen edge can temporarily limit or fully block touchscreen operation.
The Dutch inspectorate has published a manufacturer field safety notice after two reports of the Audiolyser ADL Connect producing a 250 Hz tone far above the level set in Audiowin software.
A Brainlab field safety notice, published by Dutch inspectorate IGJ, says registration may fail or give unusable results in under-twos when Cranial EM is used with Universal Atlas 6.0.
Medtronic has released clinician programmer software 2.1.4148, which includes a firmware update addressing a previously reported fault in which the Vanta implantable neurostimulator stops working after cardioversion.
Philips Medizin Systeme Böblingen has issued a field safety notice after finding its Dual IBP Adapter cannot keep defibrillation protection when two non-defibrillation-proof transducers are connected together.
Medline has initiated a recall, market exit and discontinuation of all Medline-brand beds, rails, mattresses and accessories (e.g., pendants, motor boxes) over a potential fire hazard and entrapment risk that may cause patient injury or death, and is updating customers on its repair-and-replace program. Facilities and QA/PV staff using these devices should check inventory, follow the repair/replace instructions and report any related adverse events.
Terumo BCT has notified customers using Spectra Optia apheresis systems on software 12.1, with Health Canada noting a possible treatment delay if the AIM system cannot be disabled.
Beaver-Visitec International has recalled certain Mini Blades units after finding an intermittent "open seal" condition that means sterility cannot be guaranteed, Health Canada reports.
Nine General Procedure Tray configurations are affected after Becton Dickinson asked for discontinuation of infusion sets used with the BD Alaris pump module model 8100.
A typographical error on the front of the carton misstates the hydrochlorothiazide strength as "12. mg"; the MHRA says the tablets are unaffected and supply should continue.
IsoTis OrthoBiologics is voluntarily removing specific Accell Connexus lots in Canada after possible particulate contamination linked to contact between a ball spring and the mixing container during manufacture.
Carestation 850 and 850c systems can deliver a lower concentration of anaesthetic agent than intended, according to a Health Canada recall notice for Datex-Ohmeda, Inc.
The list names Abiomed, Dexcom, Medtronic, Siemens and others; its title and description give different months, so teams should check the dates at source.
Health Canada lists a Type I recall of the Surfacer system's Workstation Sheath and Dilator after four complaints, two involving adverse events.
Certain lots of Fresenius Kabi Canada's anticoagulant sodium citrate 4g/100mL have manufacturing-related leak defects; Health Canada advises bag-by-bag checks rather than withdrawal.
Health Canada lists a Type II recall of OptiCross catheters covering revised flushing guidance, reinforced air-management practices and forthcoming Instructions For Use updates.
QuidelOrtho has confirmed that certain generations of Vitros A1c slides may produce positively biased results, with 58 complaints received and no adverse events reported as of 15 October 2026.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.