Issue Date: June 24, 2026
Issued by: Center for Biologics Evaluation and Research
Topic(s): Clinical – Medical
Status: Draft
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
Download the Guidance Document
