Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
Menstrual Products – Performance Testing and Labeling Recommendations
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 The FDA recognises this, and in this draft guidance it offers a refined framework to decide when a Comparative Efficacy Study (CES) is really needed — and when it may be safely omitted. […]
New FDA Draft Guidance: Elevating Safety, Transparency & Testing for Menstrual Products
Introduction In October 2025, the FDA published a draft guidance titled Menstrual Products – Performance Testing and Labeling Recommendations (Draft Guidance for Industry and FDA Staff).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 […]
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. […]
Title: Decoding the FDA’s New Data Submission Framework for Acute Leukemia Trials: A Step Toward Smarter, Faster, and Safer Approvals
Introduction: Setting a New Benchmark in Oncology Research The U.S. Food and Drug Administration (FDA) has taken a major stride in refining how clinical trial data for acute leukemia treatments are organized, analyzed, and submitted. With the release of the Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute […]
E20 Adaptive Designs for Clinical Trials
Introduction & Context In June 2025, the International Council for Harmonisation (ICH) released a draft guideline titled “Adaptive Designs for Clinical Trials (E20)”, currently under public consultation. U.S. Food and Drug Administration This draft, intended to harmonize global regulatory and scientific expectations, addresses the use of adaptive designs in confirmatory clinical trials (i.e., trials intended […]