Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Arizona, Florida, Nebraska, Ohio and Wisconsin become co-plaintiffs in an amended complaint alleging deceptive health-data sharing and unfair billing and cancellation practices.
Portugal's medicines authority says it held four bilateral meetings and discussed AI, new approach methodologies and patient involvement at the ICMRA summit and plenary, held 3–6 November.
Daniel Lee admitted conspiracy to commit health care fraud and money laundering over claims for unnecessary prescription drugs and adult day care services never delivered, the US Justice Department said.
The Oncology Center of Excellence draft covers first-in-human trials and products with limited human experience; comments are open until 11 January 2027.
Spain's human medicines committee gave favourable opinions to new generic products, including anticoagulants, kinase inhibitors and diabetes combinations, with the next meeting set for 1 December 2026.
The French regulator's refreshed situation update lists contrast media currently available from Bayer and Bracco, and says tensions have persisted since a change in distribution circuit.
The agency has replaced its October list with a November 2026 version naming UK companies whose licences to manufacture or wholesale medicines have been terminated, cancelled or revoked.
The regulator has replaced October's file with a November 2026 CSV listing sites granted manufacturing or wholesale dealer licences, a monthly resource for checking supply-chain partners.
The UK regulator replaced the October 2026 MS and MANSA site registers with November 2026 versions on 10 November, continuing its roughly monthly update cycle.
France's medicines agency has issued an exceptional, temporary substitution recommendation after Sanofi production problems disrupted European supplies of the fixed-dose rifampicin/isoniazid tablet.
JAZMP has called on wholesalers to temporarily bring in two strengths of cefaclor oral suspension from other EU states, with bridging quantities set for six months.
Italy's medicines agency has published a document for companies on referencing bibliographic sources in promotional materials, via its Office for Medicines Information and Advertising Oversight.
The Czech medicines agency's draft list, dated 10 November 2026, sets out reimbursed PZLÚ products, manufacturer prices, reimbursement levels and co-payments, and is open for comment until the 20th of the month.
France's medicines agency has issued a temporary recommendation after Sanofi production problems disrupted European supplies of the rifampicin/isoniazid combination, and has capped distribution.
Italy's medicines agency has issued a document from its advertising oversight office setting out how companies should use bibliographic references in promotional materials for medicinal products.
The agency's 2026 orphan approvals list for new BLAs covers six products, with approval dates from 26 March to 30 October 2026.
Italy's medicines agency has pushed back the 16 November 2026 deadline for haptens lacking commercial clinical alternatives, keeping them available for allergy diagnosis.
Denmark's medicines agency lists Novartis Healthcare's fingolimod 0.25 mg hard capsules as affected by manufacturing difficulties, with the notice last updated on 10 November 2026.
The Danish Medicines Agency reports ongoing supply difficulties for Ferring's desmopressin nasal spray Octostim 1.5 mg/ml, with a stated expected period running to early February 2027.
The list names Abiomed, Dexcom, Medtronic, Siemens and others; its title and description give different months, so teams should check the dates at source.
Italy's medicines agency has pushed back the 16 November 2026 deadline for using haptens in patch tests where no marketed clinical alternative exists.
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.
SÚKL has called for proposals for a Specific Treatment Programme covering oral ferrous sulfate heptahydrate for neonates and young children, as no suitable product is marketed in the Czech Republic.
Two Commission Implementing Decisions dated 9 November 2026 add to the lists of harmonised standards references for medical devices and in vitro diagnostics, according to DG SANTE.
Implementing Decision (EU) 2026/2481 changes the 2021 decision listing standards that give manufacturers a presumption of conformity, with sterilisation of healthcare products affected.
Implementing Decision (EU) 2026/2479 updates the list of harmonised standards under the Medical Devices Regulation across seven product and process areas.
Czech regulator SÚKL has approved a variation to STAMICIS 1 mg, raising the heating temperature, shortening incubation, allowing dilution with saline and capping vial withdrawals at ten.
SÚKL says Erdostein Zentiva 300 mg hard capsules can be dispensed without a prescription from 29 October 2026, though the product is not yet marketed in the Czech Republic.
Implementing Decision (EU) 2026/2481 updates the IVDR harmonised standards list for sterilisation of health care products and defers withdrawal of the earlier version of EN ISO 11137-1.
Implementing Decision (EU) 2026/2479 amends Decision 2021/1182, reflecting revised standards on sterilization, clinical investigation, condoms, biological evaluation, washer-disinfectors, electrical equipment and small-bore connectors.
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.