121 STAT. 876
PUBLIC LAW 110–85—SEPT. 27, 2007 for children, health care providers, parents, and others of labeling changes made as a result of such testing; (2) the number and importance of drugs and biological products for children that are not being tested for their use notwithstanding the provisions of this title and title V and possible reasons for the lack of testing; (3) the number of drugs and biological products for which testing is being done and labeling changes required, including the date labeling changes are made and which labeling changes required the use of the dispute resolution process established pursuant to the amendments made by this title, together with a description of the outcomes of such process, including a description of the disputes and the recommendations of the Pediatric Advisory Committee; (4) any recommendations for modifications to the programs established under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health Service Act (42 U.S.C. 284m) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation; and (5)(A) the efforts made by the Secretary to increase the number of studies conducted in the neonate population; and (B) the results of those efforts, including efforts made to encourage the conduct of appropriate studies in neonates by companies with products that have sufficient safety and other information to make the conduct of the studies ethical and safe.
TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
Best Pharmaceuticals for Children Act of 2007. 21 USC 301 note.
SEC. 501. SHORT TITLE.
This title may be cited as the ‘‘Best Pharmaceuticals for Children Act of 2007’’. SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT.
(a) PEDIATRIC STUDIES OF DRUGS.— (1) IN GENERAL.—Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended to read as follows: ‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
dkrause on GSDDPC44 with PUBLAW
‘‘(a) DEFINITIONS.—As used in this section, the term ‘pediatric studies’ or ‘studies’ means at least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies. ‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.— ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), if, prior to approval of an application that is submitted under section 505(b)(1), the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall
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