Decision: Advertising Investigations: May 2025
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
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Electronic Common Technical Document (eCTD) submissions update
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.
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Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue
Infusion pumps released with incorrect software can experience unexpected performance problems, including issues with essential functions and risk measures. -
Meijer Issues Recall on Frederik’s Dark Chocolate Almonds Due to Presence of Undeclared Cashews
GRAND RAPIDS, Mich., June 13, 2025 – Meijer is announcing a recall of certain packages of Frederik’s Dark Chocolate Almonds because they may also contain dark chocolate-covered cashews, which are not declared on the label. People who have an allergy or severe sensitivity to cashews run the risk of a -
What’s New Related to Drugs
Want to know what’s new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc. -
Fuentes Farms, LLC Recalls Product Because of Possible Health Risk
Fuentes Farms of McAllen, Texas is recalling 71 Boxes of Fresh Cucumbers, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy -
Pulmonary-Allergy Drugs Advisory Committee Roster
This page contains the Pulmonary-Allergy Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee. -
What’s New in Regulatory Science
A newsletter on regulatory science for CDER’s stakeholders -
First major overhaul of medical device regulation comes into force across Great Britain
New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.
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Device specific vigilance guidance: Inferior vena cava (IVC) filters
Guidance for manufacturers of IVC filters. It outlines specific scenarios that should be considered when determining if an incident is reportable.
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Guidance: Field safety notice (FSN): what it is and why it’s important
A flyer to circulate to customers alongside a field safety notice covering what it is and why it’s important to take action.
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Device specific vigilance guidance: Artificial Heart Valves
Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable.