Business · 20/12/2019

FDA Releases Draft Guidance on Demonstrating Effectiveness for Human Drugs and Biological Products

The Food and Drug Administration (FDA) has released a draft guidance document titled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products," which aims to provide clarity on the types of evidence needed to meet the substantial evidence standard for human drug and biological products, particularly in the context of emerging disease treatments and rare diseases. The guidance complements the 1998 guidance and seeks to address the evolving needs of the pharmaceutical industry.