Safety signals, PRAC recommendations, DHPCs, Drug Safety Update, MedWatch and risk minimisation.
The EMA has published a PSUSA outcome for pooled, virus-inactivated human plasma, with the regulatory result recorded as 'maintenance'.
The EMA has published the periodic safety update report single assessment for ethosuximide, with a regulatory outcome of 'maintenance' and a list of nationally authorised products.
Nova Biomedical's Gen 2.0 hospital meters can retain prior patient or QC information on screen, risking results being filed to the wrong record; a software fix is planned for November 2026.
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.
Italy's medicines agency has published a DHPC after reports that the metal seal on certain Caelyx vials may not be firmly fixed, risking sterility and occupational exposure.
Council Decision (EU) 2026/2471 fixes the EU stance for the Joint Committee on amending provisions that implement the veterinary protocol to the EU–Denmark/Faroe Islands Agreement.
Germany's two medicines safety authorities join the international social media campaign, which urges patients and health professionals to report suspected side effects rather than ignore them.
The Council has fixed the EU's stance for the Joint Committee under the EU–Denmark/Faroe Islands Agreement, covering changes to provisions implementing the Protocol on veterinary matters.
Medline is discontinuing all its branded beds and accessories, with repair, replacement or refund offered, after reports of two deaths and 16 serious injuries linked to fire and entrapment hazards.
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.
SÚKL says online offers and intermediary services directing prescription medicines to patients may amount to unlawful mail-order dispensing, and it warns of inspections and sanctions.
Spain's medicines agency has issued its August–September 2026 safety bulletin, covering vitamin D overdose errors, meningioma with desogestrel and etonogestrel, ritlecitinib restrictions and new label safety information.
The document sets out scientific conclusions, grounds for variation, amended Product Information and an implementation timetable for valproate medicines, under reference EMA/PASS/0000287665.
The Paul-Ehrlich-Institut and BfArM have published the third 2026 issue of their joint quarterly bulletin, with features on a live vaccine reassessment and intravitreal therapy risks.
The German regulator is promoting the 2–8 November campaign, stressing that spontaneous reports of suspected adverse reactions remain central to post-authorisation safety monitoring.
At its senior-level meeting in Brussels on 27 and 28 October, the committee also followed up on its recent opinion on extreme heat and heatwaves.
The Dutch inspectorate IGJ has published a manufacturer warning on the LUISA, TIVAN, LS and Life One ventilator range, citing a possible communication failure of the battery.
FDA's device centre has flagged a potentially high-risk issue after B. Braun found a missing solvent step left some dialyzer connectors inadequately bonded in three lots.
The agency has updated its blood and tissue safety notice, asking establishments to take the affected areas into account during donor interviews and selection.
FDA's biologics centre has posted a draft guidance on individualised genome-editing products, new blood donation compliance policies, immune globulin lot withdrawals and a run of approval documents.
The Dutch health inspectorate says the latest app version addresses a previously reported vulnerability and a signal-loss problem some users had after the previous update.
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 EMA's pharmacovigilance committee has released its recommendations on safety signals adopted at its latest plenary, though the detail was not available at the time of writing.
EMA's pharmacovigilance committee has released extracts of product information wording linked to signals it adopted at its 28 September–1 October 2026 meeting.
The Slovenian agency's latest bulletin for healthcare professionals covers a change in the formulation and preparation of Amoksiklav oral suspension and the mechanisms behind adverse drug reactions.
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.
The outcome of PSUSA/00001026/202512 for diacerein is a regulatory variation, with CMDh conclusions and product information amendments published on 23 October 2026.
Commission Decision (2026) 7741 of 23 October 2026 withdraws the authorisation for Trizivir (abacavir/lamivudine/zidovudine); the reason is not stated in the available source.
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.