Regulatory Blog

Clinical trials have traditionally been conducted using separate protocols to evaluate individual drugs for specific diseases or patient populations. While this approach has contributed significantly to medical innovation, it can be resource-intensive, time-consuming, and challenging when studying rare diseases or rapidly evolving therapeutic areas. To improve the efficiency of clinical development, the FDA issued the draft guidance "Master Protocols for Drug and Biological P

Demonstrating that a drug works as intended is one of the most important requirements for FDA approval. Before a new drug or biological product can reach patients, sponsors must provide strong scientific evidence showing that the product delivers meaningful clinical benefits. To clarify current expectations, the FDA issued the draft guidance "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products." The guidance explains how sponsors can est

Selecting an appropriate starting dose for first-in-human (FIH) clinical trials is one of the most critical decisions in drug development. An initial dose that is too high may expose participants to unnecessary safety risks, while a dose that is too low may provide limited scientific value and delay clinical development. To support safer and more informed dose selection, the FDA released the draft guidance "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Mini