s 13 42586 1174968000 false 1174968000 993 120 110 300022

3/27/2007--Introduced.<br/>Pediatric Research Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct an applicant seeking to waive submission requirements related to pediatric assessments of the safety and effectiveness of a drug or biological product to submit to the Secretary of Health and Human Services documentation detailing why a pediatric formulation cannot be developed. Requires an applicant seeking to defer submission of some or all of such assessments to submit to the Secretary a timeline for the completion of pediatric studies.<br/>Requires the Secretary to create an internal committee to review pediatric assessment requests issued, pediatric assessments conducted, and deferral and waiver requests. Considers a supplement to a new drug or biological license application proposing a labeling change as a result of any pediatric assessments to be a priority supplement. Sets forth dispute resolution procedures for labeling changes for pediatric drugs.<br/>Requires the Commissioner of the Food and Drug Administration (FDA) to make available to the public the medical, statistical, and clinical pharmacology reviews of pediatric assessments.<br/>Requires the Secretary to: (1) require sponsors of the assessments that result in labeling changes to distribute such information to physicians and other health care providers; (2) ensure that all adverse event reports that have been received for such a drug are referred to the Office of Pediatric Therapeutics for one year after a labeling change; and (3) contract with the Institute of Medicine to study and report to Congress regarding the pediatric studies conducted pursuant to FFDCA since 1997.<br/>Requires the Comptroller General to report to Congress on the effectiveness of FFDCA provisions relating to pediatric studies in ensuring that medicines used by children are tested and properly labeled.<br/>

1174968000 2007-03-27 Fri Nov 07 14:22:07 -0600 2008 introduced 42586 'act':4 'improv':3 'pediatr':1 'research':2 49690 short introduced 42586 'bill':2 'improv':4 'pediatr':5 'research':6 45349 official action 42586 1174968000 Tue Mar 27 00:00:00 -0500 2007 107476 Introductory remarks on measure. (CR S3842) C001041 1947-10-26 38260 Hillary 'd':4 'ny':5 'sen':1 'clinton':3,7,9 'hillari':2,6,8 F 300022 Clinton Hillary_Clinton Rodham Sen. Hillary Clinton [D, NY] 14835 N00000019 25674 Democrat Methodist NY Hillary Clinton 3.32330827067669 D000388 1944-05-27 11885 448 Russell Senate Office Building http://dodd.senate.gov/index.php?q=node/3130 202-228-1083 Christopher 'd':4 'ct':5 'sen':1 'dodd':3,7,9 'christoph':2,6,8 M 300034 Dodd Christopher_Dodd J. Sen. Christopher Dodd [D, CT] 6770 N00000581 15371 Democrat 202-224-2823 Roman Catholic CT Chris Christopher Dodd 1.83653846153846 http://dodd.senate.gov SenChrisDodd action 42586 1174968000 Tue Mar 27 00:00:00 -0500 2007 107476 Introductory remarks on measure. (CR S3842) introduced 42586 1174968000 Tue Mar 27 00:00:00 -0500 2007 107475 action 42586 1174968000 Tue Mar 27 00:00:00 -0500 2007 115992 Sponsor introductory remarks on measure. (CR S3842) action 42586 1174968000 Tue Mar 27 00:00:00 -0500 2007 107477 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.