Placeholder Banner

BIO Comments on FDA Draft Guidance on Use of Expansion Cohorts in First-In-Human Clinical Trials

October 12, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.

BIO welcomes FDA’s efforts to provide clear guidance on the regulatory and scientific framework for designing and conducting adaptive trial designs in which different aspects of a drug can be assessed in a single clinical trial while enrolling the minimum number of study participants necessary.

BIO’s comments cover topics including sample sizes, the need for flexibility, and balancing safety and efficacy. BIO encourages the FDA to consider expanding the use of the guidance beyond oncology.

Download Full Comments Below
FINAL BIO Letter Expansion Cohorts FIH 10-12-18
Read full comment letter below
Discover More
We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated…
The Biotechnology Innovation Organization (BIO) is pleased to respond to the U.S. Department of Agriculture’s (USDA) Solicitation of Input from Stakeholders on Agricultural Innovations. BIO applauds USDA for taking a proactive approach and seeking…
July 31, 2020 Re: Docket No. FDA–2020-N-0837: Raare Disease Clinical Trial Network; Request for Information. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the…