Meranda Parascandola

April 4, 2025

Why PDUFA VII User Fees Are on the Rise in 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

How to Exercise FDA Inspection Readiness

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

BLA vs. NDA: What’s the Difference?

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

What to Expect from CBER Breakthrough Approvals in 2025

The Center for Biologics Evaluation and Research (CBER) plays a critical role in overseeing the approval of innovative biologic products, including gene therapies, cell-based treatments, and vaccines. While CBER and the Center for Drug Evaluation and Research (CDER) jointly evaluate breakthrough therapy designations, CBER focuses on advanced biologics, ensuring timely […]
April 25, 2025

When Should You Consider Drug Product Development Services?

Navigating the complexities of drug development demands more than internal resources. From overcoming technical hurdles and avoiding costly or inappropriate development paths to meeting regulatory standards, every stage—discovery to market—presents unique challenges. At key moments, companies must recognize when external expertise isn't just helpful but crucial. Partnering with the right […]
May 2, 2025

FDA CVM vs. USDA CVB: Understanding the Differences in Veterinary Drug and Biologic Approvals 

Introduction  Navigating the regulatory landscape for veterinary pharmaceuticals and biologics can be complex. The U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) and the U.S. Department of Agriculture’s Center for Veterinary Biologics (USDA CVB) oversee different aspects of veterinary product approvals. FDA CVM regulates veterinary drugs under […]
May 6, 2025

Veterinary GMP Audits: Ensuring Compliance for FDA and USDA Regulations 

Good Manufacturing Practice (GMP) audits play a critical role in ensuring the safety, quality, and efficacy of veterinary pharmaceuticals and biologics. These audits assess compliance with regulatory requirements set forth by agencies such as the FDA’s Center for Veterinary Medicine (CVM) and the USDA’s Center for Veterinary Biologics (CVB). Non-compliance […]
May 6, 2025

Trends in Veterinary Drug Development: Addressing the Challenges of Companion Animal Medicines 

The veterinary pharmaceutical industry is at a crossroads as shifting consumer behaviors, economic pressures, and evolving market demands shape the future of companion animal medicines. While the global animal health market continues to grow, stagnation in the small animal sector and a decline in canine wellness visits have presented significant […]
May 6, 2025

The Importance of Analytical Processes in Animal Health Product Development 

When it comes to developing safe, effective, and compliant animal health products, analytical processes play a critical—yet often underappreciated—role. Whether for veterinary pharmaceuticals, biologics, or medicated feeds, the rigor and precision of analytical methods are central to ensuring product quality, consistency, and regulatory approval.  At DSI, we partner with veterinary […]
May 7, 2025

The Rise of Biologicals: How Regulatory Changes Are Shaping the Future of Veterinary Medicines  

The animal health industry is undergoing a significant transformation as biologicals gain traction over traditional pharmaceuticals. Driven by advancements in veterinary biotechnology, shifting market demand, and evolving regulatory frameworks, biologicals are increasingly becoming the preferred choice for disease prevention and treatment in animals. As regulatory agencies like the FDA Center […]
May 7, 2025

Conditional Approvals for Veterinary Drugs: A Faster Path to Market?   

Introduction Bringing a new veterinary drug to market is a time-consuming and resource-intensive process. To address urgent animal health needs, the FDA’s Center for Veterinary Medicine (CVM) offers the Conditional New Animal Drug Approval (CNADA) process, which provides an expedited pathway for certain veterinary drugs. This blog explores how the […]