Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability

May 4, 2022

Lab technician looking at a computer monitor with in a labratory.

May 2022

Guidance Document

Download the Final Guidance Document

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.”  This draft guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage setting.

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.

TAGS: FDA North America IND DNA Agency Alerts Regulatory Sciences

Related Articles

Agency Alerts

May 25, 2017

FDA Approves 1st Drug to Treat Cancer Based on Genetics of Tumor, Not Location

On Tuesday, May 23rd, the FDA granted accelerated approval to Merck & Co.’s Keytruda® (pembrolizumab), a product to treat cancers with a specific genetic feature (also known as a biomarker)....

Continue reading the blog post
FDA

April 29, 2022

Ulcerative Colitis: Developing Drugs for Treatment

Guidance Document April 2022. The purpose of this guidance is to help sponsors in the clinical development of drugs to treat adults with ulcerative colitis (UC). This guidance addresses the Food and...

Continue reading the blog post
Medical Devices

February 12, 2019

FDA Issues Draft Guidance to Advance Development of Combination Products

On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...

Continue reading the blog post