GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.
CBER says the company's stem cell and exosome IV offerings are unapproved new drugs and unlicensed biological products, and that the umbilical cord product is not a homologous-use HCT/P.
The German regulator has published a manufacturer safety notice for the 6008 CAREsystem, but the listing itself does not describe the hazard or the corrective actions.
The Danish Medicines Agency expects Epistatus 10 mg oromucosal solution from SERB S.A. to be affected from early to late November 2026, citing manufacturer delays.
The Danish Medicines Agency says production problems are disrupting supply of the live infectious bursal disease vaccine, with disruption expected from late September to mid-December 2026.
Denmark's medicines agency expects supply problems with Trisenox 2 mg/ml arsenic trioxide concentrate from end April to end September 2027, citing production problems at the company.
The Danish Medicines Agency says higher demand is behind disruption to Viatris ApS's gabapentin 600 mg film-coated tablets, with supply expected to be affected from late August to mid-December 2026.
A federal jury found Sophie Dufort guilty of conspiracy, health care fraud and kickback offences involving forged or purchased prescriptions for braces that beneficiaries did not want or need.
The UK regulator's monthly digest announces new antidepressant patient-information measures and the withdrawal of the IXCHIQ chikungunya vaccine's marketing authorisation, alongside a device safety note on CRRT.
Germany's federal medicines and devices authority has posted a manufacturer advisory on Syriflow MR, but the public listing does not describe the problem or the corrective actions.
Germany's medicines and devices authority has posted a Medtronic Urgent Field Safety Notice for the Abre Venous Self-expanding Stent System, with details held in an attached manufacturer advisory.
Germany's regulator has posted an Urgent Field Safety Notice from Olympus Winter & Ibe GmbH covering four electrosurgical cable products, with details held in the manufacturer's attached notice.
The German regulator has posted a manufacturer advisory covering the aerstent TBY, a non-active special implant, but the public listing does not describe the issue or the affected products.
A Class 2 recall covers every batch of the company's unlicensed clopidogrel oral solution and suspension produced before notification, with patients to be traced and reviewed.
CBER has pushed the expiry of the only US-licensed coral snake antivenin lot from 30 June to 31 December 2026, citing stability data.
EOF has published a recall decision covering a batch of BLAYCO Electrode tip cleaner and DORMO-STRIP Vein strippers, both made by TELIC S.A.U.
Ravimiamet's laboratory has been formally attested by the European OMCL network following an international Mutual Joint Audit assessing its quality system against ISO/IEC 17025 and network requirements.
The Danish Medicines Agency says Cheplapharm's Zyprexa 10 mg powder for solution for injection is affected by production problems, with disruption expected from October to the end of November 2026.
The Danish Medicines Agency lists Orifarm's olanzapine powder for solution for injection as affected by delivery difficulties, with no end date given.
The Danish Medicines Agency reports delivery difficulties affecting olanzapine injection powder, with disruption expected from early September to early November 2026.
The Danish Medicines Agency reports delivery difficulties with olanzapine powder for solution for injection from Paranova Danmark ApS, with no end date given.
DKMA says delivery difficulties are affecting Prizapin 100 mg tablets from Nordic Prime ApS, with the expected end of the disruption listed as unknown.
Austria's regulator says it will carry out GMP inspections outside the EU/EEA only where a link to an EU/EEA authorisation exists, with importers bearing the costs.
Austria's regulator says it can inspect non-EU API sites, but only where value is added in Austria or the substance is on the Union list of critical medicines.
Austria's medicines agency says imports for EU/EEA products routed through Austria must be handled by an Austria-based company, which bears inspection costs including travel.
Austria's medicines authority has published an FAQ on third-country GMP inspections, covering eligibility, timing, importer duties and how travel and inspection costs are charged.
Austria's BASG says French authorities have notified it of ID WNV NAT testing for blood and blood components in a list of départements where West Nile virus cases occurred.
Germany's BfArM has listed a ConvaTec field safety notice for US-sourced Stomahesive Paste, but the public entry does not describe the problem or the corrective actions.
The Danish Medicines Agency reports current supply problems for Viatris ApS's gabapentin 600 mg film-coated tablets, with disruption expected from mid-June to mid-November 2026.
The Danish Medicines Agency reports a supply disruption of Clozapin 'Accord' 100 mg tablets, ongoing since August 2026 with no end date given, attributed to production problems.
The Danish Medicines Agency reports supply difficulties with Viatris' clozapine 100 mg tablets, expected from late October 2026 to early April 2027 and attributed to increased 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.