FDA Presses Nicotine Pouch Makers to Adopt Child-Resistant Packaging
Background & Key Findings On September 2, 2025, the U.S. Food and Drug Administration (FDA) issued a formal call urging manufacturers of nicotine pouches to implement child-resistant packaging, responding to a dramatic rise in accidental exposures — particularly among very young children U.S. Food and Drug Administration+1. From April 1, 2022 through March 31, 2025, […]
Blog: FDA Urges Strict Adherence to Safe Use of Hyperbaric Oxygen Therapy Devices
1. Context & Safety Warning On August 25, 2025, the FDA issued a Letter to Health Care Providers, reminding clinicians and facilities of the critical importance of following manufacturer instructions when using hyperbaric oxygen therapy (HBOT) devices—given rising reports of serious injuries and fatalities U.S. Food and Drug Administration. Key recommendations include: The FDA emphasized […]
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 […]