Category Archives: Pharmaceutical Industry

510(k) vs. De Novo vs. PMA: How to Choose the Right FDA Submission Pathway in 2026

Launching a medical device in the United States begins with one of the most important regulatory decisions you'll make—determining the correct FDA premarket submission pathway. Should you submit a 510(k), pursue a De Novo Request, or prepare a Premarket Approval (PMA) application? The answer depends on your device's intended use, technological characteristics, risk classification, and

FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

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 Releases Generic Drug User Fee Amendments (GDUFA)

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

Not All Supplements are Created Equal…

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

OTC Drug Dosage Form Modifications

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

OMUFA Facility Fees for FY 2025

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)

An eye-opener on the FDA expectations for importers, distributors and private labelers of dietary supplements!!!

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