Regulatory Blog

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 To clarify current expectations, the FDA issued the draft guidance "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products."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

Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...