Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 05-6332

Summary

The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for AGRYLIN (anagrelide), CLOLAR (clofarabine), and DIFLUCAN (fluconazole). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.

Supplementary Information

I. Background FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for AGRYLIN (anagrelide), CLOLAR (clofarabine), and DIFLUCAN (fluconazole). The summaries are being made available consistent with section 9 of the BPCA (Public Law 107-109). Enacted on January 4, 2002, the BPCA reauthorizes, with certain important changes, the pediatric exclusivity program described in section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a). Section 505A permits certain applications to obtain 6 months of marketing exclusivity if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population. One of the provisions the BPCA added to the pediatric exclusivity program pertains to the dissemination of pediatric information. Specifically, for all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of pediatric studies conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are to be made available not later than 180 days after the report on the pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent with this provision of the BPCA, FDA has posted on the Internet ( http://www.fda.gov/cder/pediatric/index.htm ) summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for AGRYLIN (anagrelide), CLOLAR (clofarabine), and DIFLUCAN (fluconazole). Copies are also available by mail (see ADDRESSES ). II. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/cder/pediatric/index.htm . Dated: March 22, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05-6332 Filed 3-30-05; 8:45 am]