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The Prescription Drug User Fee Act (PDUFA) has been a cornerstone of the U.S. Food and Drug Administration’s (FDA) drug approval process since its inception in 1992. With the implementation of PDUFA VII (2023-2027), user fees for FY 2025 have been published, reflecting a notable increase that will impact pharmaceutical […]

FDA inspections are a critical aspect of regulatory compliance for pharmaceutical, biotech, and medical device companies. A well-prepared organization can navigate inspections smoothly, avoid compliance violations, and maintain operational efficiency. This article outlines the key steps companies should take to ensure FDA inspection readiness. Understanding FDA Inspections The U.S. Food […]

Navigating the regulatory pathways for drug approvals in the U.S. can be complex, especially when determining whether a Biologics License Application (BLA) or a New Drug Application (NDA) is the appropriate route. While both serve as formal requests for market approval from the FDA, they apply to different types of […]