FDA UPDATE The new QMSR and the FDA inspections – be aware!!!! IN a few short weeks, a major change in the FDA regulations pertaining to the manufacturing of medical devices since 1997 will go into effect. The FDA is changing the Quality System Regulations (QSR) to the Quality Management System Regulations (QMSR). What does
FDA Update FY 2026 Government Shutdown and how it will AFFECT the FDA Operations Update As of October 1, 2025, no Fiscal Year (FY) 2026 appropriation or Continuing Resolution (CR) has been enacted for the U.S. Food and Drug Administration (FDA). As a result, the agency has entered a lapse in funding and is operating
FDA Update FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products The FDA just announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products. The user-friendly platform allows users to
FDA Update FDA to Grant a Registration Fee Waiver if Financial Hardship is Proven The FDA again – Gives it and then Takes it Away. Originally, it looked good for a 2026 small business FDA registration fee. Supposedly, small business could be exempted from the Annual Registration fee which will rise to over $11,000 in
FDA Update FDA Releases Generic Drug User Fee Amendments (GDUFA) The FDA has released Fiscal Year 2026 user fee rates across multiple programs. While many of these updates apply broadly, the Generic Drug User Fee Amendments (GDUFA) directly impact facilities involved in generic drug manufacturing and submissions. GDUFA FY 2026 Highlights: These fees apply differently
FDA UPDATE Medical Device User Fee Amendments (MDUFA) FY2026 – !Exciting News for Small Businesses! The FDA has officially released the Medical Device User Fees for FY2026, and there’s great news for small business firms! For the first time ever, the FDA is offering a waiver for the Annual Establishment Registration Fee—a huge win for
FDA Update Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act Final Guidance The U.S. Food and Drug Administration’s Center for Devices and Radiological Health’s new presentation, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of
FDA Update Not All Supplements are Created Equal… Amazon Faces a Lawsuit Over Mislabeled Dietary Supplements A class action lawsuit has been filed against Amazon, alleging that the company sells dietary supplements with misleading labels and without proper FDA disclaimers, essentially marketing them as drugs without FDA approval. The lawsuit claims that Amazon promotes supplements
FDA Update – June 25, 2025 Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers We are seeing more and more regulatory actions against foreign companies because of lack of FDA QSR compliance. When a company has a violative inspection, and the FDA does not accept their corrective
FDA Update FDA Proposes Requirements for How Requestors Can Make Minor Dosage Form Changes to Certain Over-the-counter Monograph Drugs The U.S. Food and Drug Administration (FDA) is proposing requirements for how requestors can make minor dosage form changes to certain over-the-counter (OTC) monograph drugs. FDA issued Proposed Administrative Order OTC000038 that, if finalized, will specify
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