Unlocking Flexibility: FDA’s 2025 Guidance on pH Adjuster Waivers for Complex Generics
Introduction The guidance addresses how generic-drug applicants (via an Abbreviated New Drug Application, ANDA) may request a waiver under 21 CFR 314.99(b) of the requirement in 21 CFR 314.94(a)(9)(iii) and (iv) that inactive ingredients (specifically pH adjusters) in a generic product be qualitatively (Q1) and quantitatively (Q2) the same as the Reference Listed Drug (RLD), […]
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 […]
Essential Guide: Registering as a Medicinal-Product Broker in Ireland
Brief and Easy Explanation The document is the Health Products Regulatory Authority (HPRA)’s Guide to Registration Requirements for Brokers of Medicinal Products in Ireland. It spells out what companies or individuals must do if they act as a broker (i.e., arrange sales or purchases) of medicinal products (for human use) in Ireland under the Directive […]
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 […]
Erosive Esophagitis: Developing Drugs for Treatment
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Erosive Esophagitis: Developing Drugs for Treatment.” The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for […]