FDA Suspends Biologics License for Ixchiq: A Safety-Driven Pivot
What Happened? On August 22, 2025, the FDA’s Center for Biologics Evaluation and Research (CBER) suspended the biologics license for Ixchiq® (VLA1553)—Valneva’s live-attenuated chikungunya vaccine—citing serious safety concerns. The decision is grounded in evidence that the vaccine may be causing chikungunya-like illness, including encephalitis, hospitalizations, and fatalities.citeturn0search0turn0search1 This move follows a prior May 9, 2025 […]
FDA Launches Real-Time Reporting of Adverse Event Data
A Leap Toward Transparency & Speed On August 22, 2025, the U.S. Food and Drug Administration (FDA) initiated daily publication of adverse event data from its FAERS database—a move designed to revolutionize how safety information is shared with the public U.S. Food and Drug Administration. The FDA Commissioner, Marty Makary, M.D., M.P.H., emphasized that “adverse […]
Qfitlia (fitusiran): a practical, evidence-based look at the newly approved hemophilia prophylaxis
Summary: On March 28, 2025 the U.S. FDA approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce bleeding in people 12 years and older with hemophilia A or B — with or without factor inhibitors. Qfitlia is an antithrombin-lowering, subcutaneously administered therapy that aims to restore thrombin generation rather than replacing missing clotting factors. […]
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 […]
FDA Safety Labeling Changes for ACTEMRA (tocilizumab): What Changed, PV & Regulatory Impact, and a Playbook for Shudarsana
What changed in the U.S. label Newest update (August 8, 2025): Recent prior update (September 2024): Practical takeaway: Two concurrent risk domains now shape operations—expanded pediatric COVID-19 use (dosing, handling, benefit–risk) and heightened vigilance for severe hypersensitivity/SCARs. FDA Access Data+1 What needs to change internally (manufacturer/MAH “to-do” list) Pharmacovigilance impact Signal detection & case processing […]
Recent Safety Labeling Changes for BYOOVIZ
On August 15, 2025, the FDA approved safety-related labeling changes for BYOOVIZ (ranibizumab-nuna, BLA-761202) FDA Access Data. Key updates include: Impact on Pharmacovigilance Processes 1. Enhanced Signal Detection and Monitoring 2. Case Processing & Reporting 3. Update of Safety Documents 4. Risk Communication Impact on Regulatory Strategy 1. Labeling and Submission Updates 2. Compliance with […]
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 […]
Empowering Safe Innovation: FDA’s Predetermined Change Control Plan (PCCP) Guidance for AI-Enabled Medical Device Software Functions – A Regulatory, Pharmacovigilance, MAH, and Impact Perspective
1. Regulatory Perspective In April 2023, the FDA issued draft guidance introducing the Predetermined Change Control Plan (PCCP) framework. Its goal: to enable AI/ML-enabled device software functions (AI-DSFs) to be updated safely, effectively, and more swiftly, without requiring new submissions for each iteration Data Matters Privacy BlogU.S. Food and Drug Administration. These adjustments reflect the […]