Sec. 4. Report to improve development of new drugs and biologic products to treat childhood cancers
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Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall report to Congress on barriers to studying oncologic therapies in pediatric populations under section 505B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c ). The report under subsection
(a)shall include— an assessment of the feasibility of requiring studies for a pediatric oncologic indication under section 505B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c ) if the therapeutic target of a drug or biologic product for an adult oncologic indication is highly relevant to any pediatric cancer to which it could apply; recommendations to overcome any barriers identified in the report on how to improve research, development and access to new oncologic therapies for use in pediatric patients; and an assessment of the potential impact of altering the exemption under subsection
(k)of such section 505B. The report under subsection
(a)shall be developed with input from relevant stakeholders.
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Sec. 4
Report to improve development of new drugs and biologic products to treat childhood cancers
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