Page:United States Statutes at Large Volume 121.djvu/888

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[121 STAT. 867]
[121 STAT. 867]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 867

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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 and pediatric patients, the Secretary may conclude that pediatric effectiveness can be extrapolated from adequate and well-controlled studies in adults, usually supplemented with other information obtained in pediatric patients, such as pharmacokinetic studies. ‘‘(ii) EXTRAPOLATION BETWEEN AGE GROUPS.—A study may not be needed in each pediatric age group if data from one age group can be extrapolated to another age group. ‘‘(iii) INFORMATION ON EXTRAPOLATION.—A brief documentation of the scientific data supporting the conclusion under clauses (i) and (ii) shall be included in any pertinent reviews for the application under section 505 of this Act or section 351 of the Public Health Service Act (42 U.S.C. 262). ‘‘(3) DEFERRAL.— ‘‘(A) IN GENERAL.—On the initiative of the Secretary or at the request of the applicant, the Secretary may defer submission of some or all assessments required under paragraph (1) until a specified date after approval of the drug or issuance of the license for a biological product if— ‘‘(i) the Secretary finds that— ‘‘(I) the drug or biological product is ready for approval for use in adults before pediatric studies are complete; ‘‘(II) pediatric studies should be delayed until additional safety or effectiveness data have been collected; or ‘‘(III) there is another appropriate reason for deferral; and ‘‘(ii) the applicant submits to the Secretary— ‘‘(I) certification of the grounds for deferring the assessments; ‘‘(II) a description of the planned or ongoing studies; ‘‘(III) evidence that the studies are being conducted or will be conducted with due diligence and at the earliest possible time; and ‘‘(IV) a timeline for the completion of such studies. ‘‘(B) ANNUAL REVIEW.— ‘‘(i) IN GENERAL.—On an annual basis following the approval of a deferral under subparagraph (A), the applicant shall submit to the Secretary the following information:

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