Food and Drug Administration proposed testing guidelines for developmental toxicity studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration.
Regul Toxicol Pharmacol
; 30(1): 39-44, 1999 Aug.
Article
en En
| MEDLINE
| ID: mdl-10464045
The Food and Drug Administration (FDA) is the agency responsible for ensuring that the direct food additives and color additives used in food in the United States are safe for all consumers. In 1982, in an effort to provide guidance concerning appropriate tests, the FDA issued Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, commonly known as the Redbook. The Redbook included detailed guidelines for testing the effects of direct and indirect food and color additives on mothers and their developing fetuses. Based on refinements in safety assessment and risk evaluation as well as expansion of knowledge concerning the metabolism and pharmacokinetics of food and color additives, the need to revise and update the 1982 document became apparent. In 1993, Redbook II in draft form was made available for public comment. Since then, test end points and developmental landmarks have been refined. The latest proposed guidelines for developmental toxicity studies are provided here.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Guías como Asunto
/
Pruebas de Toxicidad
/
Desarrollo Embrionario y Fetal
Tipo de estudio:
Guideline
Límite:
Animals
/
Female
/
Humans
/
Pregnancy
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Año:
1999
Tipo del documento:
Article
País de afiliación:
Estados Unidos
Pais de publicación:
Países Bajos