The FDA lacks direct oversight of natural medical cannabis products due to its classification as a Schedule I substance.

Blog written by Stephanie Illich Stroll exclusively for Boston Biotech Advisors LLC. In the pharmaceutical industry, ensuring the safety,...

The FDA’s 510(k) pathway is a critical regulatory route for bringing new medical devices to market in the United States.

In a significant regulatory update, the FDA has introduced changes to the Quality Management System Regulation (QMSR).

The U.S. Congress passed a landmark piece of legislation known as the 21st Century Cures Act, setting the stage for a new era in...

Navigating the complex landscape of regulatory compliance and business strategy can be daunting for entrepreneurs. That's where we step in.

In the labyrinth of regulations governing biotechnology and pharmaceuticals, compliance is the cornerstone of success. Compliance is...