Center for Drug Evaluation and Research (U.S.). (2004). Guidance for industry: Changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes. U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research.
Chicago Style (17th ed.) CitationCenter for Drug Evaluation and Research (U.S.). Guidance for Industry: Changes to an Approved NDA or ANDA, Specifications, Use of Enforcement Discretion for Compendial Changes. Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2004.
MLA (9th ed.) CitationCenter for Drug Evaluation and Research (U.S.). Guidance for Industry: Changes to an Approved NDA or ANDA, Specifications, Use of Enforcement Discretion for Compendial Changes. U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2004.