Blogs

April 4, 2025
Published by Meranda Parascandola at 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 […]
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April 4, 2025
Published by Meranda Parascandola at 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 […]
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April 25, 2025
Published by Meranda Parascandola at 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 […]
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May 2, 2025
Published by Meranda Parascandola at 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 […]
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May 6, 2025
Published by Meranda Parascandola at 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 […]
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