Safety signals, PRAC recommendations, DHPCs, Drug Safety Update, MedWatch and risk minimisation.
The EMA's PRAC has released the final translations of product information text for phenobarbital, linked to a targeted signal management procedure.
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.
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.
The European Medicines Agency has released a draft guideline on veterinary good pharmacovigilance practices (VGVP) covering a list of medically important VeDDRA terms.
The draft guideline would replace the current appendix to the VGVP signal management module, with comments open until 31 January 2027 alongside a separate consultation on the module's revision.
The US antitrust agency says combining the two largest distributors to veterinary clinics would raise prices and erode service quality across animal health supply.
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.
Austria's regulator relays a Danish notice that European Sperm Bank has blocked the donor's gametes, though use for siblings of existing donor-conceived children remains possible.
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.
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.
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.
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 US agency is prolonging, with modifications, its moratoria on new hospice and home health agency enrolment by six months, citing fraud, waste and abuse.
A new EMA web page outlines expected outcomes of AI use across the EU network and compiles a timeline of milestones from 2021 to August 2026.
DG SANTE and the EMA have agreed with Singapore's Health Sciences Authority to exchange information on medicines and medical devices, with immediate effect.
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.
Health Canada lists a Type I recall of the Surfacer system's Workstation Sheath and Dilator after four complaints, two involving adverse events.
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.
Arizona, Florida, Nebraska, Ohio and Wisconsin become co-plaintiffs in an amended complaint alleging deceptive health-data sharing and unfair billing and cancellation practices.
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.
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.
The US regulator has upgraded the Abiomed action to its most serious category, citing quality issues in heart pump controllers that could delay therapy or cause loss of haemodynamic support.
FDA CBER says postmarketing reports include tumours with vector integration near the GLI1 oncogene, and it is weighing regulatory action on Zolgensma and Itvisma.
The European Medicines Agency has released a document setting out pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026.
The agency has published Revision 1 of its draft guideline on assessing medicinal products' risks in human reproduction and breastfeeding, covering the path from data to product information.
The FDA has upgraded its Early Alert on Presource convenience kits containing BD Alaris Pump infusion sets to a Class I recall, its most serious category.
Eugia US is recalling one lot of vancomycin for injection to hospital level after a glass particle was identified inside a vial; no adverse events have been reported.
The US Centers for Medicare & Medicaid Services has distributed $10bn across all 50 states in the second year of its programme to strengthen rural healthcare.
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.