Drug Substances U.S. Department of Health and Human Services Food and Drug Administration Center / /
IndustryTerm
abbreviated new drug applications / normal manufacturing variations / chemical reactions / crude products / certain new drug applications / herbal products / possible degradation products / generic drug products / semisynthetic products / chemical syntheses / normal manufacturing / chemical development studies / manufacturing process / /
MedicalCondition
MS / /
Organization
Chemistry / Manufacturing / and Controls Coordinating Committee / U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation / HFD-2 IO Center for Drug Evaluution and Research / Center for Drug Evaluation and Research / Food and Drug Administration / Training and Communications Division of Communications Management Drug Information Brauch / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation / FDA Ad Hoc Advisory Committee / office of Training / / /
Guidance for Industry ANDAs: Impurities in Drug Substances U.S. Department of Health and Human Services Food and Drug Administration