United States. Food and Drug Administration. Office of Combination Products & Center for Biologics Evaluation and Research (U.S.). (2004). Guidance for industry and FDA staff: Submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product. U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products.
Chicago Style (17th ed.) CitationUnited States. Food and Drug Administration. Office of Combination Products and Center for Biologics Evaluation and Research (U.S.). Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product. Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products, 2004.
MLA (9th ed.) CitationUnited States. Food and Drug Administration. Office of Combination Products and Center for Biologics Evaluation and Research (U.S.). Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product. U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products, 2004.