Pharmaceutical PopSci Regulation

The 25-Year FDA Novel Drug Approval and Indication Matrix

By analyzing historical data from the FDA’s Center for Drug Evaluation and Research (CDER) alongside prominent industry benchmarks over the past 25 years (2001 to 2025), a clear story emerges. CDER approved 951 novel drugs during this period. However, the...
Pharmaceutical PopSci Regulation

The basics about nonclinical toxcitiy study director

 What Is a Nonclinical Toxicity Study Director? Before any experimental medicine enters a human body in a Clinical Trial, it must pass a battery of rigorous safety evaluations in the laboratory. At the center of this...