Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
FDA's enforcement report lists a Class II recall of Teva Pharmaceuticals USA's metoclopramide tablets, with nationwide US distribution and the recall still ongoing.
The nationwide US recall of sermorelin from Houston Rx LLC, numbered D-0041-2027, is listed as ongoing in the FDA's enforcement report dated 21 October 2026.
The EU regulator has issued its list setting reference dates and frequencies for periodic safety update report submissions; the entry-level details were not available to VigiEye.
The outcome of the periodic safety update report single assessment for alendronate, procedure PSUSA/00000078/202601, was published on 21 October 2026 and leads to a variation.
The marketing authorisation holder has pulled its prior evaluation request for osilodrostat in endogenous Cushing's syndrome, and INFARMED has posted the public report on Infomed.
The New Jersey compounder says analytical data from its own laboratory were inconsistent, so affected products may be subpotent or superpotent; 98 complaints have been received, 7 of them serious.
Medtronic has revised the Abre self-expanding venous stent IFU to add an approved manual deployment alternative, aimed at limiting harm if a stent is only partially deployed.
EOF has published a decision recalling specific lots of NEUROPACK straight plates and a sterile fast flap kit with a large bur hole, but the notice excerpt gives no reason or lot numbers.
Germany's medicines and devices regulator has listed an urgent field safety notice from Trinity Biotech covering an oxalate reagent and the kit that contains it, with details in the manufacturer's advisory.
Germany's regulator lists an urgent notice for Coltene/Whaledent's translucent esthetic post system, flagging a labelling problem and the absence of EU market permission.
SÚKL has published a notice from Janssen-Cilag on the interruption of supplies of Invega 9 mg tablets in the 49-tablet pack, giving no cause or restart date.
Czech regulator reports that Accord's 120-tablet packs were supplied with an out-of-date patient information leaflet lacking updated adverse reactions.
Following a consultation that drew 1,056 responses, the government intends to legislate for indefinite recognition and to align MDD transition timelines in Great Britain with the EU's.
The government has decided CE marked devices and IVDs approved for the EU will keep access to the GB market long term, following a consultation with over 1,000 responses.
Companies can now apply electronically to the German regulator for exemption from the extra rebate that applies from 1 January 2027, ahead of the rule taking effect.
Italy's medicines agency has revised the nivolumab registry after a determination was published in the Official Gazette, allowing neoadjuvant immunotherapy in advanced NSCLC settings.
The agency has issued final guidance on applying its drug labelling authorities to certain software outputs disseminated by or for sponsors, finalising a September 2023 draft.
A periodic safety update report single assessment of intravenous amino acid combinations has ended with a 'maintenance' outcome, according to EMA's publication of 20 October 2026.
The CHMP is assessing whether Rifadin 20 mg/ml oral suspension and syrup should stay on the EU market, as its marketing authorisation holder has not proposed a diethanolamine-free formulation.
A single assessment of periodic safety update reports for hydroxyethyl starch products ends with a 'maintenance' outcome, according to the EMA's 15 October 2026 publication.
The UK regulator has revised its 2014 SSRI and SNRI safety page to reflect a review of how certain risks are explained to patients.
The UK regulator's update on 15 October 2026 links an 'Antidepressants – updated safety communications' report within its collection of national medicines safety assessments.
Apothecary Pharma's NAD+ Injection 200 mg/mL is subject to an ongoing nationwide US recall, classified Class II for lack of assurance of sterility.
The US regulator's enforcement report records an ongoing nationwide recall of Sterile Eye Drops Redness Relief (glycerin 0.25%) because sterility cannot be assured.
The Class II recall of compounded sermorelin acetate 1 mg/ml injectable cites formulation with bacteriostatic water and processing equipment, and remains ongoing across the US.
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.