BIO Comments on FDA Draft Guidance on Use of Expansion Cohorts in First-In-Human Clinical Trials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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.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.
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.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.