FDA warns against unapproved epinephrine nasal solutions from BPI Labs & Endo USA: what happened, why it matters, and what to do now
Key takeaways What the FDA alert actually says On Jan 16, 2025, the FDA told health care professionals not to use unapproved epinephrine nasal solutions from BPI Labs and Endo USA because they’re being mistaken for injectable epinephrine. The agency emphasized that the nasal products are not sterile, so any IV administration could cause infection […]
FDA Warning Letter to Vacation, Inc. (Aug 6, 2025): What Happened, Why It Matters, and What Comes Next
On August 6, 2025, the FDA issued a Warning Letter to Vacation, Inc. over its “Classic Whip” sunscreens sold in mousse/whipped-cream style canisters. The agency says these products are misbranded and illegally marketed because the foam dosage form isn’t permitted under today’s OTC sunscreen rules—and because the packaging closely resembles edible whipped cream, creating a […]
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 […]
Philips Respironics BiPAP A30 / A40 / V30 — Continuous Ventilator Correction, Clinical Risks, and Manufacturer Action Plan
Source: FDA Medical Device Recalls page (updated Aug 6, 2025).Link reviewed: FDA recall notice for Philips Respironics update of use instructions for BiPAP A30, A40, and V30 due to interruptions and/or loss of therapy. U.S. Food and Drug Administration Executive summary Philips Respironics issued an urgent device correction for all lots of the BiPAP A30, […]
Early Alert: Boston Scientific ENDOTAK RELIANCE Defibrillation Leads — investigative report, clinical guidance, and manufacturer action plan
Source: FDA Early Alert (posted Aug 6, 2025). U.S. Food and Drug Administration Executive summary (two sentences) The FDA posted an Early Alert after Boston Scientific notified clinicians that certain ENDOTAK RELIANCE defibrillation leads with ePTFE-coated shock coils are showing coil calcification that correlates with a gradual rise in low-voltage shock impedance (LVSI) and can […]
Early Alert: Medline ReNewal Reprocessed EP Catheters with Residual Particulates – What You Need to Know
Date of FDA Page Update: August 6, 2025 U.S. Food and Drug Administration The device and product details These catheters are used for electrophysiology (EP) mapping, stimulation, and recording in diagnosing and managing cardiac arrhythmias via endocardial and intravascular access. U.S. Food and Drug Administration Reason for the Early Alert Medline ReNewal found that affected […]
FDA & CDC Recommend Pause of IXCHIQ (Chikungunya Vaccine, Live) for Adults 60+ — An Investigative Update
Published: May 12, 2025 (FDA safety communication).Quick summary: The FDA and CDC have recommended a temporary pause in the use of IXCHIQ® (Chikungunya Vaccine, Live) for people 60 years and older while agencies investigate postmarketing reports of serious neurologic and cardiac events, including deaths. This article explains what’s known, what the agencies are doing, who’s […]
FDA Requires New Class Warning for mRNA COVID-19 Vaccines: Myocarditis/Pericarditis Update (June 2025)
Meta title (≤60 chars): FDA adds myocarditis warning to mRNA COVID-19 shotsMeta description (≤155 chars): FDA now requires updated warnings on Pfizer and Moderna mRNA COVID-19 vaccines, with new incidence estimates and post-marketing findings. TL;DR What exactly did FDA do? The new label language—what’s different? Why the update now? FDA determined new safety information met […]