Drug Safety

The FDA Amendments Act And Drug Safety: Twenty Years Later

The FDA Amendments Act of 2007 (FDAAA) expanded FDA's authority to monitor drugs post-approval, mandating a population-based surveillance system and new disclosure rules. Twenty years later, progress is clear but the overall safety impact remains hard to quantify, offering key lessons for pharma BD and investors.

FDA Warning Letters: Understanding Pharmaceutical Compliance Actions and Their Impact on Drug Safety

FDA warning letters serve as critical regulatory tools for pharmaceutical compliance. Learn how these enforcement actions impact drug safety and market access.

Blockchain in Pharmaceutical Supply Chain: Ensuring Drug Safety with FDA Insights

Discover the role of blockchain technology in the pharmaceutical supply chain, enhancing drug safety and compliance with FDA insights for medications like Insulin.