Food and Drug Administration Announces Streamlined Guidance to Help Researchers Bring Cancer-Fighting Treatments to Market

Aug 24, 2018

The Food and Drug Administration (FDA) recently released new guidance documents on how to modernize clinical oncology trials. The regulatory process for human trials is rigorous. These new guidance documents seek to facilitate understanding of the process, thereby increasing the chances that innovative new therapies can be approved and brought to market.

“The approach we’re describing in new guidance today is to help innovators to evaluate drugs in trials that are potentially lower cost, more efficient, and could enable us to learn more about the safety and efficacy when compared to traditional trial designs,” FDA Commissioner Scott Gottlieb said in a recent press release.

The guidance documents provide four main sets of recommendations to help pharmaceutical companies and researchers navigate the following:

  • Characteristics of drug products best suited for consideration for development under a multiple expansion cohort trial
  • Information to include in investigational new drug application submissions to support the design of individual expansion cohorts
  • When to interact with FDA on planning and conduct of multiple expansion cohort studies
  • Safeguards to protect patients enrolled in these expansion cohort studies.

To view the new guidance documents, click here: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM616325.pdf

To watch a videocast of the webinar, click here: https://www.nibib.nih.gov/news-events/meetings-events/artificial-intelligence-medical-imaging-workshop