final product / manufacturing practice / facility product / electronic submission systems / /
Organization
U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Policy Office / office of Compliance / office of Communications Division of Drug Information / Division of Dockets Management / /
Guidance for Industry Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act DRAFT GUIDANCE