. "3 Outline of the Overall Process for Evaluation of Dietary Supplement Ingredients." Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment. Washington, DC: The National Academies Press, 2002.
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For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements
Ongoing Review and Reassessment
As new information becomes available to FDA, re-evaluation of internal draft monographs and monographs revised by an external advisory committee may be necessary. Such new information should be considered as described in the priority-setting step to determine if there is sufficient substantive new information to review and possibly revise the monograph.
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CFSAN (Center for Food Safety and Applied Nutrition). 2000. Dietary Supplement Strategy (Ten Year Plan). Online. Food and Drug Administration. Available at http://vm.cfsan.fda.gov/~dms/ds-strat.html. Accessed March 5, 2002.
Chambliss WG. 2001. Nutraceutical formulations: Impact on bioavailability. In: Examining the Science Behind Nutraceuticals: Proceedings of the AAPS Dietary Supplements Forum. Arlington, VA: AAPS Press. Pp. 367–380.
FDA (Food and Drug Administration). 1997. Current good manufacturing practice in manufacturing, packaging, or holding dietary supplements; Proposed rule. Fed Regis 62:5699–5709.
GAO (General Accounting Office). 1997. Medical Device Reporting: Improvements Needed in FDA’s System for Monitoring Problems with Approved Devices. HEHS-97–21. Washington, DC: U.S. Government Printing Office.
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