FDA Proposal to Add Bemotrizinol to Sunscreen Monograph
On Dec 11, 2025, the FDA announced a proposed order to add bemotrizinol (also known as Tinosorb S) to the OTC sunscreen monographfda.gov. This proposal – the first new sunscreen active ingredient in decades – is intended to modernize U.S. sunscreen regulation and expand broad-spectrum options. In FDA’s review, bemotrizinol “provides protection against both ultraviolet […]
TEMPO – The Digital Health Pilot by FDA
What is TEMPO? On December 5, 2025, the FDA announced the TEMPO Pilot — formally: Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot. U.S. Food and Drug Administration In other words, TEMPO does not represent a loosening of standards per se, but rather a new, risk-based regulatory approach designed specifically to accelerate adoption of […]
Elevidys Gene Therapy Under Stricter FDA Controls After Fatal Liver Injury Reports
1. Background on Elevidys 2. Trigger for Regulatory Action 3. Nature of the FDA Action (Labeling & Indication Revision) On November 14, 2025, the FDA approved revised labeling for Elevidys. Key components: 3.1 Boxed Warning 3.2 Indication Limitation 3.3 Updates to Other Labeling Sections 3.4 Monitoring and Risk-Mitigation Measures The revised labeling mandates specific monitoring […]
How to Prepare a Pre-Request for Designation (Pre-RFD)
Introduction The FDA’s guidance “How to Prepare a Pre-Request for Designation (Pre-RFD)” provides structured recommendations for sponsors seeking preliminary feedback from the Office of Combination Products (OCP) on how their product should be classified (drug, device, biologic, or combination product) and to which FDA centre (e.g.,Although this is a U.S. FDA document, its lessons and […]
Depth Article: Revisiting Hormone Replacement Therapy — A Paradigm Shift in Women’s Health
1. Background: What Changed The U.S. Food & Drug Administration (FDA), in coordination with the U.S. Department of Health & Human Services (HHS), has announced a significant regulatory reconsideration: the move to remove or revise longstanding boxed-(“black box”) warnings on many hormone replacement therapies (HRT) for menopause. U.S. Food and Drug Administration+2Science News+2These warnings have […]
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 […]
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” This guidance describes the Agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic […]
Development of Non-Opioid Analgesics for Chronic Pain
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Non-Opioid Analgesics for Chronic Pain.” This guidance is intended to assist sponsors in the development of non-opioid analgesics for the treatment of chronic pain. It describes FDA’s current recommendations regarding phase 3 trials for […]
Disseminated Coccidioidomycosis: Developing Drugs for Treatment
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Disseminated Coccidioidomycosis: Developing Drugs for Treatment.” The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species ( i.e., C. immitis […]