GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.
The UK regulator has released decisions on adverts reported as breaching medicines advertising law, with documents covering weight-loss services and websites offering medicinal treatment services.
Denmark's medicines agency says supply of Paracox-8 Vet. oral suspension is disrupted, with increased sales and demand given as the cause.
The Danish Medicines Agency says GlaxoSmithKline's meningococcal B vaccine faced shortages from April to mid-June 2026, with increased sales and demand cited as the cause.
The Florida cellular medicine manufacturer says it has received AABB's new certification, which assesses quality management only and does not evaluate its cellular products.
A software issue on DxC 500 AU Clinical Chemistry Analyzers may reset custom test units to system defaults without telling users, according to a field safety notice published by the Dutch inspectorate IGJ.
Complaint investigations confirmed the reagent lot exceeds the within-lab imprecision limit of 7.0% CV on Atellica CH and CI analysers, according to a Dutch inspectorate listing.
The Dutch inspectorate has published a manufacturer warning on a Medartis scaphoid plate whose locking contours ended up on the convex underside after being bent in the wrong direction.
Denmark's medicines agency reports delivery difficulties for Sandoz's clozapine 100 mg tablets, expected to last from October 2026 to the end of January 2027.
The Danish Medicines Agency says increased demand has disrupted supply of Frivelle 1.5 mg tablets from Orifarm Generics, with the notice updated on 3 November 2026.
Ravimiamet says a falsified version of the dental cream, sold via Poland's Allegro platform, may have reached Estonia and could contain agents not meant for use in the mouth.
German regulator publishes a BS Medical Tech notice covering Tumorstent, Innoflex, Innosoft, Innostar, Percudrain and Percusof kits, but the listing gives no details of the problem.
Health Canada has published a Type I recall of CWP 800 systems from Vantive Health GmbH, citing defective circuit breakers and a medical-device performance issue.
BfArM has published a manufacturer field safety notice for the Atellica CH APO B assay, but the issue, affected lots and user actions appear only in an attached advisory.
HHS OIG reports the sentence over the dispensing of more than 300,000 oxycodone 30mg pills to patrons with no medical need for the drug.
Violetta Mailyan was sentenced for billing Medicare more than $45 million for Botox injection services that were medically unnecessary and never provided, HHS OIG reports.
A guilty plea in a $227 million scheme centres on stolen beneficiary data used to bill Medicare for COVID-19 test kits that were never provided, according to HHS OIG.
Germany's medicines and devices authority has listed an urgent field safety notice from Medtronic Inc for its MyPTM App, a medical app; details sit in the manufacturer's Advisory Notice.
The Danish Medicines Agency lists Orifarm's Cellcristin 1 mg/ml solution for injection as affected by delivery difficulties, with disruption expected to run until the end of March 2027.
The Danish Medicines Agency lists the end of Victoza (liraglutide) 6 mg/ml pre-filled pen marketing as a permanent cessation for commercial reasons.
The Danish Medicines Agency has flagged upcoming supply problems for Pfizer's sulfasalazine gastro-resistant tablets, attributing them to increased sales and demand.
Denmark's medicines agency says Valneva Sweden AB's IXCHIQ will face supply difficulties for about two years, citing commercial reasons.
The Danish Medicines Agency says production problems at Krka Sverige AB are disrupting supply of Nimvastid 1.5 mg hard capsules, with disruption expected from late April to mid-December 2026.
The Dutch inspectorate has published a manufacturer field safety notice dated 5 October 2026 on incompatible lead and percutaneous extension pairings in Medtronic's InterStim SureScan MRI system.
Siemens Healthineers says one production lot of its tox Serum Tricyclic Antidepressant Calibrator Control contains more sodium azide than specified, though it reports no effect on performance.
Slovakia's medicines agency has released a direct healthcare professional communication on Caelyx pegylated liposomal, citing possible loss of sterility and unintended exposure when the protective cover is removed.
Baxter Holding B.V. has reported incomplete aluminium crimping on Caelyx 50 mg/25 ml single-dose vials, which can leave the vial open when the cap is removed.
A single lot of Equate Ultra Strength Antacid Assorted Fruits chewable tablets is recalled nationally in Canada after the possible presence of stainless steel shavings, classed Type II.
Germany's medicines and devices authority has published a Philips Medical Systems Nederland field safety notice for Azurion, but the nature of the issue sits only in the manufacturer's attached advisory.
Germany's BfArM has listed an urgent field safety notice from Intersurgical Ltd. for its Smoothbore Breathing System, with all substantive details held in the manufacturer's attached advisory.
DKMA says Elanco Denmark's tiamulin-based veterinary oral solution is in short supply, with disruption expected from late April to mid-November 2026 because of increased sales and demand.
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.