The required study may cover the drug used with another active ingredient
What the document says“the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation of-- ``(i) the drug or biological product for which the application referred to in such paragraph is submitted; or”
Section 6601 rewrites section 505B(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act. The required investigation may cover the drug in the application, or that drug used with another active ingredient. The other ingredient must either have an approved generic or biosimilar application and be found by the Secretary, after consulting the applicant, to be part of the standard of care for a pediatric cancer, or have an approved application to treat an adult cancer held by the same applicant and be directed at a molecular target the Secretary finds substantially relevant to a pediatric cancer.
What the document actually says“the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation of-- ``(i) the drug or biological product for which the application referred to in such paragraph is submitted; or”
The study must look at a drug aimed at a target in a cancer cell. It may look at the drug in the application on its own.
Cancer in children is often treated with drugs used together. A study of one drug alone may not answer much. This lets the study cover the pairing.
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