Center for Biologics Evaluation and Research (U.S.) & International Conference on Harmonisation. (2005). Guidance for industry: Granularity document : annex to M4, organization of the CTD. U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research.
Chicago Style (17th ed.) CitationCenter for Biologics Evaluation and Research (U.S.) and International Conference on Harmonisation. Guidance for Industry: Granularity Document : Annex to M4, Organization of the CTD. Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005.
MLA (9th ed.) CitationCenter for Biologics Evaluation and Research (U.S.) and International Conference on Harmonisation. Guidance for Industry: Granularity Document : Annex to M4, Organization of the CTD. U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005.