Abstract
In 1966, partly in reaction to the thalidomide disaster of the 1950s and early 1960s, the U.S. Food and Drug Administration (FDA) adopted new guidelines for preclinically testing drugs for reproductive and structural defects prior to allowing them to be marketed (U.S. F.D.A., 1966).
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References
Adams, J., Buelke-Sam, J., Kimmel, C. A., Nelson, C. J., Reiter, L. W. Sobutka, T. J., Tilson, H. A., and Nelson, B. K. Collaborative behavioral teratology study: Protocol design and testing procedures. Neurobehavioral Toxicology and Teratology, 1985, 7, 579–586.
Barlow, S. M. United Kingdom: Regulatory attitudes toward behavioural teratology testing. Neurobehavioral Toxicology and Teratology, 1985, 7, 643–644.
Barlow, S. M., and Sullivan, F. M. Behavioural teratology. In C. L. Berry, and D. E. Poswillo, (Eds.), Teratology: Trends and Applications. New York: Springer-Verlag, 1975, 103–120.
Buelke-Sam, J., Kimmel, C. A., Adams, J., Nelson, C. J., Vorhees, C. V., Wright, D. C., St. Omer, V., Korol, B. A., Butcher, R. E., and Wayner, M. J. Collaborative behavioral teratology study: Results. Neurobehavioral Toxicology and Teratology, 1985, 7, 591–624.
Canada, Health and Welfare. Preclinical Toxicological Guidelines. Ottawa: Health and Welfare, 1981. Pp. 34–49.
Collins, T. F. X. Reproduction and teratology guidelines; review of deliberations by the national toxicology advisory committee’s reproduction panel. Journal of Environmental and Pathological Toxicology, 1978, 2, 141–147.
Committee for Proprietary Medicinal Products. Guidance to Applicants for Marketing Authorization of New Drugs on the Conduct of Reproduction Studies. Paris: Secretariat, 1977.
European Economic Community, Reproduction studies: Notes for guidance concerning the application of Chapter I (C) and (D) of part 2 of the Annex to Directive 75/318/EEC, with a view to the granting of a marketing authorization for a new drug. Official Journal of the European Communities, 1983, 322, 20–22.
Federation of Societies for Experimental Biology, Life Sciences and Research Office. Neurotoxicity and Behavioral Dysfunction. Bethesda, Md: Federation of Societies for Experimental Biology, 1985.
Frankos, V. H. FDA perspectives on the use of teratology data for human risk assessment. Fundamental and Applied Toxicology, 1985, 5, 615–626.
Hattan, D. G., Henry, S. H., Montgomery, S. B., Bleiberg, M. J., Rulis, A. M., and Bolger, P. M. Role of the Food and Drug Administration in regulation of neuroeffective food additives. In R. J. Wurtman, and J. J. Wurtman, (Eds.), Nutrition and the Brain (vol. 6). New York: Raven Press, 1983, 6, pp. 31–99.
Japanese Ministry of Health and Welfare. Information on the Guidelines of Toxicity Studies Required for Applications for Approval to Manufacture (Import) Drugs (Notification No. 118.) Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, February 15, 1984, Tokyo.
Nolen, G. A. An industrial developmental toxicologist’s view of behavioral teratology and possible guidelines. Neurobehavioral Toxicology and Teratology, 1985, 7, 653–657.
Nordic Council on Medicine. Drug Applications, Nordic Guidelines (NLN Publication No. 12) 1983.
Quoted by Tanimura, T. Guidelines for developmental toxicity testing of chemicals in Japan. Neurobehavioral Toxicology and Teratology, 1985, 7, 647–652.
Reubl, K. R., and Chang, L. W. Effects of methylmercury on the development of the nervous system: A review. Neurotoxicology, 1979, 1, 21–55.
Tanimura, T. Guidelines for developmental toxicity testing of chemicals in Japan. Neurobehavioral Toxicology and Teratology, 1985, 7, 647–652.
United Kingdom, Committee on Safety of Medicine. Notes for Guidance on Reproduction Studies. London: Department of Health and Social Security, London. 1973.
United Kingdom, Department of Health and Social Security. Medicines Act 1968: Guidance Notes on Applications for Product Licenses. London: HMSO, 1984.
U.S. Environmental Protection Agency. New and Revised Health Effects Test Guidelines (PB No. 83-257691). Washington, DC: Office of Pesticides and Toxic Substances, 1983.
U.S. Environmental Protection Agency. New and Revised Health Effects Test Guidelines. (PB No. 84-233295). Washington, DC: Office of Pesticides and Toxic Substances, 1984.
U.S. Environmental Protection Agency. Toxic substances control act test guidelines. Final rules. Federal Register, 1985, 50, 39,252–39,516.
U.S. Food and Drug Administration. Guidelines for Reproduction Studies for Safety Evaluation of Drugs for Human Use. Washington, D.C.: Food and Drug Administration, 1966.
U.S. Food and Drug Administration. Advisory Committee on Protocols for Safety Evaluation: Panel on reproduction studies in safety. Toxicology and Applied Pharmacology, 1970, 16, 264–296.
Vorhees, C. V. Comparison and critique of government regulations for behavioral teratology. In E. P. Riley and C. V. Vorhees, (Eds.), Handbook of Behavioral Teratology. New York: Plenum Press, 1986, pp. 49–66.
Yakuji Nippo, Inc. Requirements for the Registration of Drugs in Japan. Tokyo: Yakuji Nippo, 1982.
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© 1989 Plenum Press, New York
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Abel, E.L. (1989). Regulatory Protocols for Identifying Teratogens. In: Behavioral Teratogenesis and Behavioral Mutagenesis. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-0735-8_8
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DOI: https://doi.org/10.1007/978-1-4613-0735-8_8
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