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
CST Technologies, Inc. has been a longtime client of MDI, and we’re proud to have played a role in helping them reach this milestone. CST Technologies: Engineering the Future of Diagnostics Life Sciences Reiew Before synthetic biology captured headlines, CST Technologies was already reshaping the diagnostics landscape. For over four decades, the company has specialized
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
FDA Update – January 17, 2025 FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency The FDA has issued a new draft guidance to help developers validate diagnostic tests (IVDs) for emerging pathogens during public health emergencies. This guidance aims to ensure that
FDA Update FDA Releases Draft Guidance on Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations FDA Issues Draft Guidance to Improve Accuracy and Address Bias in Pulse Oximeters The FDA has released a draft guidance document aimed at improving the accuracy of pulse oximeters and addressing concerns
FDA Update BD receives FDA warning letter over quality system violations Becton Dickinson (BD) has received a warning letter from the FDA regarding quality system violations at a facility that manufactures its Pyxis medication management system. The FDA identified several concerns, including: Failure to adequately investigate complaints: The FDA found over 92,000 complaints related to
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