Important Update for Healthcare Professionals: Opella Healthcare France
On 24 October 2025, the pharmaceutical company Opella Healthcare France S.A.S. (on behalf of the product) issued a letter to healthcare professionals notifying of a new contraindication for Phenergan oral formulations (25 mg film-coated tablets and 5 mg/5 ml oral solution). HPRA Assets What’s Changed Why This Matters The new contraindication recognises the risk of […]
Safeguarding Children’s Oral Health: A New Chapter by the U.S. Food and Drug Administration
What’s Happening? On October 31, 2025, the FDA issued a landmark announcement titled “U.S. Food and Drug Administration Acts to Protect Children from Unapproved Fluoride Drug Products”. U.S. Food and Drug Administration+1 The gist of the action is that the FDA is moving to restrict the sale and use of ingestible fluoride prescription drug products […]
Essential Guide: Registering as a Medicinal-Product Broker in Ireland
Brief and Easy Explanation The document is the Health Products Regulatory Authority (HPRA)’s Guide to Registration Requirements for Brokers of Medicinal Products in Ireland. It spells out what companies or individuals must do if they act as a broker (i.e., arrange sales or purchases) of medicinal products (for human use) in Ireland under the Directive […]
PRIME: priority medicines
What is the PRIME scheme? The PRIME (Priority Medicines) scheme is a regulatory support programme established by the European Medicines Agency (EMA). It is designed to enhance support for the development of medicines that target an unmet medical need, by providing early and intensified interaction with developers, so that promising therapies can reach patients more […]
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
Why this guidance matters In the evolving world of biologics and biosimilars, precise head-to-head clinical trials are expensive, lengthy and sometimes redundant. The FDA recognises this, and in this draft guidance it offers a refined framework to decide when a Comparative Efficacy Study (CES) is really needed — and when it may be safely omitted. […]
Accelerating Biosimilar Development: A Key Move by the FDA
On October 29, 2025, the FDA announced that it is taking major steps to make it faster and less costly to develop biosimilar medicines—the lower-cost alternatives to biologic drugs that treat many serious and chronic diseases. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2 Specifically, the agency released a draft guidance titled “Scientific Considerations […]
New FDA Draft Guidance: Elevating Safety, Transparency & Testing for Menstrual Products
Introduction In October 2025, the FDA published a draft guidance titled Menstrual Products – Performance Testing and Labeling Recommendations (Draft Guidance for Industry and FDA Staff). U.S. Food and Drug AdministrationThis guidance provides non-binding recommendations for manufacturers of menstrual products (tampons, pads, menstrual cups) regarding performance testing, specification, materials/disclosure, and labeling. U.S. Food and Drug […]
EMA partners with content creators to promote safe and responsible use of GLP-1 medicines
What the announcement says The EMA has launched its first social-media campaign to raise awareness of the safe and responsible use of GLP-1 receptor agonist medicines. European Medicines Agency (EMA)Key points: Why this step is important Several reasons why EMA’s initiative is both timely and significant: For someone in the healthcare or medical-store business (such […]
Unlocking the Future of Drug Development: How the FDA’s New Radiolabeled Mass-Balance Study Guidance Is Changing the Game
🧠 Article: The U.S. Food & Drug Administration (FDA) has released a pivotal guidance document — “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies” — which outlines its current thinking on when and how to conduct human radiolabeled mass-balance studies of investigational drugs. U.S. Food and Drug Administration Here’s a breakdown of what this […]