April 4, 2025
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 […]
April 4, 2025
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 […]
April 4, 2025
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 […]
April 4, 2025
The path to FDA drug approval involves several critical milestones, one of the most important being the Pre-New Drug Application (Pre-NDA) meeting. This crucial step provides pharmaceutical companies with an opportunity to engage with the FDA before submitting a New Drug Application (NDA). Understanding the significance of a Pre-NDA meeting […]
April 4, 2025
For early-stage drug developers, engaging with the FDA at the right time can be critical to success. One such opportunity is the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting. This meeting provides early-stage guidance from the FDA’s Center for Biologics Evaluation and Research (CBER) and Center […]
March 28, 2025
Navigating the complexities of regulations in pharmaceuticals, biotechnology, or medical devices demands precision and expertise. Current Good Manufacturing Practices (cGMP) compliance isn’t optional—it drives business success and safeguards public trust. cGMP quality compliance consulting transforms these challenges into opportunities by crafting targeted strategies and delivering actionable guidance to ensure your […]
