117 STAT. 1936
PUBLIC LAW 108–155—DEC. 3, 2003
Public Law 108–155 108th Congress An Act Dec. 3, 2003 [S. 650]
To amend the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require certain research into drugs used in pediatric patients.
Pediatric Research Equity Act of 2003. 21 USC 301 note.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Pediatric Research Equity Act of 2003’’. SEC. 2. RESEARCH INTO PEDIATRIC BIOLOGICAL PRODUCTS.
USES
FOR
DRUGS
AND
(a) IN GENERAL.—Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505A the following: 21 USC 355c.
‘‘SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL PRODUCTS.
‘‘(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.— ‘‘(1) IN GENERAL.—A person that submits an application (or supplement to an application)— ‘‘(A) under section 505 for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration; or ‘‘(B) under section 351 of the Public Health Service Act (42 U.S.C. 262) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration; shall submit with the application the assessments described in paragraph (2). ‘‘(2) ASSESSMENTS.— ‘‘(A) IN GENERAL.—The assessments referred to in paragraph (1) shall contain data, gathered using appropriate formulations for each age group for which the assessment is required, that are adequate— ‘‘(i) to assess the safety and effectiveness of the drug or the biological product for the claimed indications in all relevant pediatric subpopulations; and ‘‘(ii) to support dosing and administration for each pediatric subpopulation for which the drug or the biological product is safe and effective. ‘‘(B) SIMILAR COURSE OF DISEASE OR SIMILAR EFFECT OF DRUG OR BIOLOGICAL PRODUCT.— ‘‘(i) IN GENERAL.—If the course of the disease and the effects of the drug are sufficiently similar in adults
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