Latest Regulatory Updates

This FDA warning letter, issued to Germaphobix (720555), addresses significant deficiencies in manufacturing processes and quality control related to a biologic product.

This FDA warning letter addresses deficiencies observed during an inspection of Genovate, specifically concerning deviations from current good manufacturing practice (CGMP) regulations for biological products.

This FDA warning letter addresses deficiencies observed during an inspection of Genetrace, specifically concerning deviations from Current Good Manufacturing Practice (CGMP) regulations for biological products.

This guidance from the MHRA clarifies the conditions under which general medical devices used within health institutions are exempt from certain regulatory requirements in the UK.

The EMA outlines its strategic priorities and planned actions for veterinary medicines up to 2025, focusing on areas like antimicrobial resistance, innovation, fees, and international collaboration.

The EMA has published a guideline outlining deadlines for submitting applications for orphan medicinal product designation and corresponding assessment timetables for valid applications from 2026 to 2027.

This guidance from the MHRA outlines the requirements for registering medical devices to place them on the UK market, detailing necessary information and processes for manufacturers.

The Committee for Veterinary Medicinal Products (CVMP) concluded its 13-14 January 2026 meeting with decisions regarding several veterinary medicinal product applications, including positive opinions and deferrals pending additional information.

This guidance from the MHRA outlines how pharmaceutical companies can obtain scientific advice to support the development and regulatory submission of new medicines, including innovative medicines, biologics, and vaccines.

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) meeting from January 12-15, 2026, addressed several safety concerns and risk mitigation measures for various medicinal products, including updates on daratumumab and Arixtra.

The FDA has issued an early alert regarding a potential issue with Boston Scientific's Stent and Electrocautery-Enhanced Delivery System, advising clinicians of a possible device malfunction that could result in incomplete stent deployment or tissue damage.

Medline is voluntarily recalling certain anesthesia circuits and anesthesia circuit kits due to a potential quality defect that could compromise the sterility of the products.

Olympus is expanding a voluntary recall of ViziShot 2 FLEX (19G) EBUS-TBNA needles due to a potential risk of needle tip disengagement during use, which could lead to inadequate tissue sampling and misdiagnosis.

Draeger is recalling Vapor 2000 and Vapor 3000 anesthetic vaporizers due to a potential quality defect that could result in inaccurate drug delivery.

The FDA has issued an early alert regarding a potential issue with AirLife Broselow Rainbow Tapes, which may result in incorrect medication dosages for pediatric patients due to printing errors.

This guidance from the MHRA details the conformity assessment procedures and requirements for medical devices seeking UKCA marking to demonstrate compliance with UK regulations post-Brexit.

The EMA outlines its strategic priorities for human medicines up to 2025, focusing on areas like accelerating access to innovative medicines, enhancing international collaboration, adapting assessment timetables, and ensuring sustainable funding through fees.

This document from the EMA provides procedural advice for users of the centralised procedure regarding post-authorisation activities, covering topics such as variations, renewals, labelf changes, and fee calculations.

The European Medicines Agency has updated its procedural advice for users of the centralised procedure, outlining tracked changes to clarify post-authorisation processes and requirements.

Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S. due to a potential software issue that may cause inaccurate readings.