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Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
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 The FDA recognises this, and in this draft guidance it offers a refined framework to decide when a Comparative Efficacy Study (CES) is really needed — and when it may be safely omitted.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 U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2 Specifically, the agency released a draft guidance titled “Scientific Considerations […]
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) […]