large volume parenteral drug product / large volume biological product / biological products / rare disease therapies / treatment of a rare pediatric disease / treatment of certain rare pediatric diseases / biological product / rare pediatric disease drug product / allergenic extract product / rare pediatric disease products / bovine blood product / human drug applications / potential rare pediatric disease product / manufacturing / rare pediatric disease product / certain tropical disease products / certain rare pediatric disease product applications / in vitro diagnostic biologic product / /
MedicalCondition
rare diseases / certain tropical disease / non-rare disease / potential rare pediatric disease / U.S. with the rare pediatric disease / rare pediatric disease / certain rare pediatric diseases / different disease / rare pediatric diseases / disease / Neglected Tropical Diseases / approved rare pediatric disease / rare disease / certain rare pediatric disease / original rare pediatric disease / diseases / Implementation disease / /
MedicalTreatment
antibiotics / /
Organization
U.S. Department of Health and Human Services / Food and Drug Administration Center for Biologics Evaluation and Research / Special Medical Programs Office / U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research / Food and Drug Administration / office of Communications / Communication / Outreach / and Development Center for Biologics Evaluation / Public Health Service / Orphan Products Development Office / G. Agency / Congress / Federal Government / Division of Dockets Management / Center for Drug Evaluation and Research / office of Orphan Products Development / Drug Information Center for Drug Evaluation / /
Person
Henry Startzman / / /
Position
Governor / Commissioner / /
Product
Prescription Drug / E11 / Generating Antibiotic / /
Rare Pediatric Disease Priority Review Vouchers, Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: November 17, 2014