BIO Comments on FDA Draft Guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics: Draft Guidance for Industry, which provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials.

BIO says this important draft guidance will help companies use adaptive trial designs to provide evidence of the effectiveness and safety of a drug or biologic. BIO suggests additional information to include in the guidance as well as how to clarify the guidance.