FDA. 2003b. FDA News. FDA Proposes Labeling and Manufacturing Standards for All Dietary Supplements. Online. Available at http://www.fda.gov/bbs/topics/NEWS/2003/NEW00876.html. Accessed July 2, 2003.
FDA. 2003c. Safety reporting requirements for human drug and biological products. Proposed rule. Fed Regis 68:12406–12497.
Finney DJ. 1971. Statistical aspects of monitoring for dangers in drug therapy. Methods Inf Med 10:1–8.
Fletcher AP. 1991. Spontaneous adverse drug reaction reporting vs event monitoring: A comparison. J R Soc Med 84:341–344.
GAO (General Accounting Office). 1992. Cross Design Synthesis: A New Strategy for Medical Effectiveness Research. GAO/PEMD-92-18. Washington, DC: GAO.
Gardner MJ, Machin D, Campbell MJ. 1986. Use of check lists in assessing the statistical content of medical studies. Br Med J 292:810–812.
Goldman SA. 1996. The Clinical Impact of Adverse Event Reporting. A MedWatch Continuing Education Article. Food and Drug Administration. Available at http://www.fda.gov/medwatch/articles.htm. Accessed February 25, 2003.
Goldman SA. 1998. Limitations and strengths of spontaneous reports data. Clin Ther 20:C40–C44.
Goldman SA, Kennedy DL, Lieberman R, eds. 1995. Clinical Therapeutics and the Recognition of Drug-Induced Disease. A MedWatch Continuing Education Article. Food and Drug Administration. Available at http://www.fda.gov/medwatch/articles.htm. Accessed June 4, 2003.
Griggs B. 1997. Green Pharmacy. The History and Evolution of Western Herbal Medicine. 2nd ed. Rochester, VT: Healing Arts Press.
Hennekens CH, Buring JE, Mayrent SL. 1987. Epidemiology in Medicine. Boston: Little, Brown.
Hill AB. 1971. Principles of Medical Statistics. 9th ed. New York: Oxford University Press.
ICH (International Conference on Harmonisation). 1995. Guidance for Industry. E3. Structure and Content of Clinical Study Reports. Rockville, MD: Drug Information Branch, Center for Drug Evaluation and Research, FDA.
Ioannidis JP, Lau J. 2001. Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas. J Am Med Assoc 285:437–443.
Ioannidis JPA, Chew P, Lau J. 2002. Standardized retrieval of side effects data for metaanalysis of safety outcomes: A feasibility study in acute sinusitis. J Clin Epidemiol 55:619–626.
Karch FE, Smith CL, Kerzner B, Mazzullo JM, Weintraub M, Lasagna L. 1976. Adverse drug reactions—A matter of opinion. Clin Pharmacol Ther 19:489–492.
Kessler DA. 1993. Introducing MEDWatch: A new approach to reporting medication and device adverse effects and product problems. J Clin Res Drug Dev 7:183–190.
Koch-Weser J, Sellers EM, Zacest R. 1977. The ambiguity of adverse drug reactions. Eur J Clin Pharmacol 11:75–78.
Lewis JA. 1981. Post-marketing surveillance: How many patients? Trends Pharmacol Sci 2:93–94.
Moher D, Schulz KF, Altman DG. 2001. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol 1:2–8.
OIG (Office of Inspector General). 2001. Adverse Event Reporting for Dietary Supplements. An Inadequate Safety Valve. Online. Food and Drug Administration. Available at http://oig.hhs.gov/oei/reports/oei-01-00-00180.pdf. Accessed February 26, 2003.
Prance GT, Chadwick DJ, Marsh J, eds. 1994. Ethnobotany and the Search for New Drugs. Ciba Foundation Symposium 185. New York: John Wiley and Sons.