Page:United States Statutes at Large Volume 121.djvu/845

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[121 STAT. 824]
[121 STAT. 824]
PUBLIC LAW 110-000—MMMM. DD, 2007

121 STAT. 824

PUBLIC LAW 110–85—SEPT. 27, 2007

Sec. 228. Inspections by accredited persons. Sec. 229. Study of nosocomial infections relating to medical devices. Sec. 230. Report by the Food and Drug Administration regarding labeling information on the relationship between the use of indoor tanning devices and development of skin cancer or other skin damage. TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007 Sec. 301. Short title. Sec. 302. Tracking pediatric device approvals. Sec. 303. Modification to humanitarian device exemption. Sec. 304. Encouraging pediatric medical device research. Sec. 305. Demonstration grants for improving pediatric device availability. Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory committee. Sec. 307. Postmarket surveillance. Sec. Sec. Sec. Sec.

401. 402. 403. 404.

TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007 Short title. Reauthorization of Pediatric Research Equity Act. Establishment of internal committee. Government Accountability Office report.

TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007 Sec. 501. Short title. Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act. Sec. 503. Training of pediatric pharmacologists. TITLE VI—REAGAN-UDALL FOUNDATION Sec. 601. The Reagan-Udall Foundation for the Food and Drug Administration. Sec. 602. Office of the Chief Scientist. Sec. 603. Critical path public-private partnerships. TITLE VII—CONFLICTS OF INTEREST Sec. 701. Conflicts of interest. TITLE VIII—CLINICAL TRIAL DATABASES Sec. 801. Expanded clinical trial registry data bank. TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS Sec. 901. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec.

902. 903. 904. 905. 906. 907. 908. 909.

Subtitle A—Postmarket Studies and Surveillance Postmarket studies and clinical trials regarding human drugs; risk evaluation and mitigation strategies. Enforcement. No effect on withdrawal or suspension of approval. Benefit-risk assessments. Active postmarket risk identification and analysis. Statement for inclusion in direct-to-consumer advertisements of drugs. No effect on veterinary medicine. Authorization of appropriations. Effective date and applicability.

Subtitle B—Other Provisions to Ensure Drug Safety and Surveillance 911. Clinical trial guidance for antibiotic drugs. 912. Prohibition against food to which drugs or biological products have been added. 913. Assuring pharmaceutical safety. 914. Citizen petitions and petitions for stay of agency action. 915. Postmarket drug safety information for patients and providers. 916. Action package for approval. 917. Risk communication. 918. Referral to advisory committee. 919. Response to the institute of medicine. 920. Database for authorized generic drugs. 921. Adverse drug reaction reports and postmarket safety. TITLE X—FOOD SAFETY

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