FDA Guidance on Medical Device Cybersecurity: A Crucial Step in Safeguarding Healthcare Technology
In an increasingly connected world, cybersecurity in healthcare technology has never been more critical. With medical devices becoming more integrated into hospital networks, clinical workflows, and patient care, their vulnerability to cyber threats has raised significant concerns. The FDA’s guidance on cybersecurity for medical devices offers essential guidelines to ensure the protection of these devices […]
FDA’s Real-Time Adverse Event Reporting Dashboard for Cosmetics: A New Era of Transparency
Published: September 2025 Imagine you bought a new shampoo, hair dye, or moisturizer. A few days later, you notice a rash, excessive itching, or even worse. What would you do? Report it—but often, you might wonder whether your report ever makes a difference. With the FDA’s launch of its new dashboard for real-time adverse event […]
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
Understanding the Guidance: What, Why, How In September 2025, the U.S. Food and Drug Administration (FDA) issued a nonbinding guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” U.S. Food and Drug Administration This document gives detailed recommendations for sponsors developing therapeutic protein biosimilars, especially how to design […]
FDA’s Guidance on Alternative Tools for Assessing Drug Manufacturing Facilities: What It Means for Pharma
In September 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance document titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.” This guidance redefines how regulators and industry navigate facility assessments for pending drug applications—including NDAs, ANDAs, and BLAs. The new framework signals FDA’s intent to use more flexible, risk-based […]
Article: FDA Issues New Guidance on Animal Studies for Dental Bone Grafting Materials
Background & Purpose On August 22, 2025, the FDA released its latest guidance titled “Animal Studies for Dental Bone Grafting Material Devices – Premarket Notification (510(k)) Submissions,” building upon the original Dental Bone Grafting Guidance from 2005 U.S. Food and Drug Administration+1. The document offers nonbinding recommendations on conducting animal studies for dental bone grafting […]
FDA Safety Labeling Change: CORTISPORIN® Ointment — What Changed, What to Update, and How Shudarsana Can Help
What changed (SrLC highlight) On Aug 8, 2025 (SUPPL-86) the FDA approved an update to Adverse Reactions adding the statement: “Skin hyperpigmentation has been reported with polymyxin B containing products.” FDA Access Data+1 This is now explicitly listed alongside other topical corticosteroid/antibiotic local reactions and informs clinicians and patients about a pigmentary risk previously not […]
Ensuring Patient Safety: FDA’s Draft Guidance on Assessing Overall Survival in Oncology Clinical Trials — A Multi-Perspective Analysis
Article 1. Regulatory Perspective The FDA’s August 2025 draft guidance outlines recommendations for evaluating Overall Survival (OS) in randomized oncology trials, particularly when OS isn’t the primary endpoint U.S. Food and Drug Administration. 2. Pharmacovigilance Perspective OS serves not only as efficacy but a critically objective safety endpoint. 3. MAH (Marketing Authorization Holder) Perspective From […]
Deep brief — Formal Meetings Between FDA and Sponsors/Applicants of BsUFA Products
Guidance for Industry (CDER & CBER, July 2025) — what it says, why it matters, and exactly what regulatory, pharmacovigilance (PV), quality, clinical and commercial teams must do day-to-day. U.S. Food and Drug Administration Quick summary (the headline) This FDA guidance codifies how sponsors of biosimilar or interchangeable biologic products should request, prepare for, run, […]
Deep Brief — Medical Device User Fee Small Business Qualification & Determination (FDA guidance, July 31, 2025)
What it is, why it matters, and exactly what manufacturers — including regulatory, PV/PS (pharmacovigilance / product safety), quality and finance teams — must do Short version: This FDA guidance explains how device and biologics firms can qualify as a “small business” for reduced MDUFA user fees (and for a one-time waiver of a first […]