Obtaining pediatric indications for new anti-epileptic drugs: How and when

Epilepsy Research

Volumn 68, Issue 1, 2006, Pages 38-42

  Garofalo, Elizabeth ^a  

^a UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT;

COMMUNITY; CONFERENCE PAPER; DRUG EFFICACY; DRUG FORMULATION; DRUG INDICATION; DRUG SAFETY; ELECTROENCEPHALOGRAM; EPILEPSY; HEALTH PROGRAM; HUMAN; MEDICAL CARE; PEDIATRICS; PRIORITY JOURNAL; SEIZURE;

ANTICONVULSANTS; CHILD; CLINICAL TRIALS; DECISION TREES; DRUG EVALUATION; EPILEPSY; HUMANS; INFANT; UNITED STATES;

EID: 30144444638     PISSN: 09201211     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.eplepsyres.2005.09.016     Document Type: Conference Paper

References (3)

1. Congress of the United States of America, 2001. Best Pharmaceuticals for Children Act. Public Law 107-109, 107th Cong. 1st Session, 3 Jan 2001. Available from: http://www.fda.gov/opacom/laws/pharmkids/pharmkids.html#begin.
2. Congress of the United States of America, 2003. Pediatric Research Equity Act of 2003 (PREA). 108th Cong. 1st Sess S. 650, 23 Jul 2003. Available from: http://www.fda.gov/opacom/laws/prea.html.
3. U.S. Department of Health and Human Services, Food and Drug Administration, 2000. Guidance for Industry - E11 Clinical Investigation of Medicinal Products in the Pediatric Population. 65 (71) Federal Register, pp. 19777-19781.