biologics license applications / drug product / gas chromatography / manufacturing practices / manufacturing methods / Appropriate chemical attribute information / degradation products / drug products / product license applications / investigational new drug applications / manufacturing process / /
MedicalCondition
MS / dissociation / /
Organization
Chemistry / Manufacturing / and Controls Coordinating Committee / U.S. Department of Health and Human Services / HFD-210 Center for Drug Evaluation and Research / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Analytical Methods Technical Committee of the Chemistry / office of Training / Training and Communications Division of Communications Management Drug Information Branch / Controls Coordinating Committee / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / office of Communications Training and Manufacturers Assistance / /
Guidance for Industry Analytical Procedures and Methods Validation