GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.
DG SANTE reports positive feedback from sponsors and Member States on the pilot for clinical investigations and performance studies under the MDR and IVDR, with more than 200 attending.
Germany's BfArM has listed an Urgent Field Safety Notice from Vascutek Ltd on its Gelweave Vascular Prosthesis; the details sit in the manufacturer's Advisory Notice.
Germany's BfArM has listed an urgent field safety notice from Löwenstein Medical for the LEONI 4, with hazard and corrective actions detailed only in the manufacturer's Advisory Notice.
A single lot of Secaris Nasal Gel, sold nationally in Canada, is subject to a Type II recall after the company found it may contain foreign matter.
Germany's medicines and devices regulator has published a manufacturer notice on the IntelliVue Patient Monitor, but the public listing does not describe the problem or the corrective action.
Germany's regulator has published a manufacturer advisory on various EPflex Feinwerktechnik guidewires, but the listing itself gives no detail on the problem or the devices affected.
Germany's BfArM has posted an Urgent Field Safety Notice from QuidelOrtho covering VITROS Chemistry Products A1c Slides, but the listing itself gives no details of the issue.
Chad Monroe admitted conspiring to bill Medicare for unwanted braces and genetic tests, with kickbacks from laboratories and telemedicine firms, and to obtaining a PPP loan fraudulently.
Kwame Raoul's office has announced charges over alleged Medicaid fraud, naming two Palos Heights women; the source gives no link to medicines or pharmaceutical firms.
Delly Shabani admitted conspiracy to commit health care fraud over mental health services billed to D.C. Medicaid that were never provided or were grossly inflated; sentencing is pending.
Two companies behind a Clarksville pain management clinic and two managers will pay $1.5m to settle False Claims Act allegations involving Medicare and VA billing for diagnostic testing.
A 31-count federal indictment in Florida charges a Jacksonville man with health care fraud and money laundering, and an accountant with money laundering.
DKMA says Lipomed GmbH's dacarbazine 500 mg infusion powder has been in short supply since April 2026, with disruption expected through December 2027 for commercial reasons.
The Nashville oncology practice self-disclosed the conduct to HHS OIG and settled allegations under the Civil Monetary Penalties Law, with damages based on the nurse's full pay and benefits.
Arizona Otolaryngology Consultants settled with HHS OIG after self-disclosing that Medicare claims for audiology services were submitted for work done by a non-enrolled individual.
The Slovenian agency has posted the month's safety corrective action notices received from manufacturers and authorised representatives, while warning that the list may be incomplete.
DKMA's updated notice attributes the shortage of Viatris ApS's 5 mg prasugrel tablets to manufacturer delays, with the disruption running from June 2025 to end-March 2027.
The Danish Medicines Agency says Viatris ApS's Prasugrel Viatris 10 mg tablets face supply difficulties, blamed on manufacturer delays, with disruption expected to run from April 2025 to March 2027.
The Danish Medicines Agency reports manufacturing problems affecting Viatris ApS's frovatriptan 2.5 mg film-coated tablets, with disruption expected from mid-May 2026 to the end of January 2028.
The Danish Medicines Agency attributes the shortage of Sandoz's 75 micrograms/24 hours HRT patch to production problems, with foreign packs permitted as an alternative.
The Danish Medicines Agency expects supply of Sandoz's estradiol patches to be disrupted from October to the end of December 2026 because of manufacturing issues.
The Danish Medicines Agency says production problems at Perrigo Sverige AB are affecting supply of NorLevo 1.5 mg levonorgestrel tablets, with the expected period running from early to mid-November 2026.
The Danish Medicines Agency reports delivery difficulties with NorLevo 1.5 mg tablets from Paranova Danmark ApS, with no end date given.
The District of Delaware has created a task force pooling federal and state agencies to pursue fraud against federal government programmes, according to a notice listed by HHS OIG.
Attorney General Josh Kaul says state prosecutors have filed criminal charges over more than $1 million in allegedly fraudulent claims submitted to Wisconsin's Medicaid programme.
The New Jersey-based laboratory group has paid $13,014,576 plus interest over claims that exclusive entertainment perks were used to induce referrals paid for by federal healthcare programmes.
Lab Genomics LLC and its owner, Leena Dalal, have agreed to pay the US government $1.25m over alleged illegal payments to marketers, according to HHS OIG.
A federal grand jury in the Southern District of Florida has charged Dr Edgard Salazar with conspiring to bill Medicare for consultations that never took place and unwanted braces.
Medline has initiated a recall, market exit and discontinuation of all Medline-brand beds, rails, mattresses and accessories (e.g., pendants, motor boxes) over a potential fire hazard and entrapment risk that may cause patient injury or death, and is updating customers on its repair-and-replace program. Facilities and QA/PV staff using these devices should check inventory, follow the repair/replace instructions and report any related adverse events.
Terumo BCT has notified customers using Spectra Optia apheresis systems on software 12.1, with Health Canada noting a possible treatment delay if the AIM system cannot be disabled.
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.