Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
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 The FDA recognises this, and in this draft guidance it offers a refined framework to decide when a Comparative Efficacy Study (CES) is really needed — and when it may be safely omitted. […]
New FDA Draft Guidance: Elevating Safety, Transparency & Testing for Menstrual Products
Introduction In October 2025, the FDA published a draft guidance titled Menstrual Products – Performance Testing and Labeling Recommendations (Draft Guidance for Industry and FDA Staff).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 […]
Putting Patients in the Driver’s Seat: How the FDA’s Latest Guidance is Changing the Game for Clinical Trials
1. What’s this all about? The U.S. Food & Drug Administration (FDA) has released a new guidance titled “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments”. U.S. Food and Drug AdministrationHere’s the gist: 2. Why this matters In the past, many clinical trials were designed and measured mainly from a “clinician/regulator” perspective. […]
Research Report — Contaminated Cough Syrups in India (Oct 2025): Scope, Data, Regulatory Response, and Public-Health Implications
Prepared for: Shudarsana Company / Regulatory & Safety StakeholdersDate: 15 October 2025 (content current as of 15 Oct 2025)Sources: FDA, Reuters, WHO-related reporting, RAPS, Chemistry World, Reuters investigative archives, peer-reviewed summaries. Key sources cited inline. Executive summary (key facts & numbers) Background: DEG/EG contamination — why it kills Diethylene glycol (DEG) and ethylene glycol (EG) […]
First Treatment Recommended for Rare Immunoglobulin-Related Autoimmune Disease
In September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended extending the indication of Uplizna® (inebilizumab) to include treatment of active Immunoglobulin G4-related disease (IgG4-RD) in adults. European Medicines Agency (EMA) IgG4-RD is a rare, chronic autoimmune disorder in which the body’s immune system attacks its own tissues, leading […]