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…
Read more →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…
Read more →New FDA Draft Guidance: Elevating Safety, Transparency & Testing for Menstrual Products
Introduction In October 2025, the FDA published a draft guidance titled Menstrual Products – Performance Testing and Labeling Recommendations (Draft Guidance for Industry and…
Read more →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…
Read more →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…
Read more →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…
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