We submitted comments to the FDA on its draft guidance for demonstrating drug effectiveness with just one pivotal trial. Expanding on our @nejm.org letter, we asked FDA to justify this shift with data, clarify vague terms, & account for risks when extrapolating trial data across diseases & products.
cspi.org
RE: FDA draft guidance on Substantial Evidence of Effectiveness for Human Drug and Biological Products
The Center for Science in the Public Interest respectfully submits these comments regarding the Food and Drug Administration’s draft guidance titled “Demonstrating Substantial Evidence of Effectivenes...