FDA Update PLEASE BE AWARE THAT THE FDA HAS LAUNCHED THE FOLLOWING PROGRAM. WHAT DOES IT MEAN TO YOU? FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources
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 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 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 December 6, 2024 COVID Public Health Emergency Exemption from Fees to Expire FDA Reminds OTC Hand Sanitizer Manufacturers of OMUFA Facility Fees for FY 2025 FDA is reminding companies who registered with the agency solely to manufacture hand sanitizer during the COVID-19 public health emergency that they are subject to fiscal year (FY)
Our analysis of recent FDA warning letters issued to the dietary supplements industry signaled the FDA turned its GMP enforcement emphasis to the importers, distributors and private labelers of dietary supplements. However, time and time again, we see that many of our clients mistakenly believe that manufacturers or contract manufacturers of dietary supplements are the
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