ABSTRACT
Section 3. Guideline for the Format and Content of Nonclinical Pharmacology/Toxicology Section of a New Drug Application A. Drug Identification B. Animals C. Route and Mode of Administration D. Doses E. Order of Presentation of Studies
Section 4. FDA User Fee Program A. Presubmission B. Postsubmission
Section 5. FDA Pregnancy Categories A. Pregnancy Category A B. Pregnancy Category B C. Pregnancy Category C D. Pregnancy Category D E. Pregnancy Category X F. Nonteratogenic Effects
Section 6. Synopsis of General FDA Guidelines for Animal Toxicity Testing Studies Table 28.1 Duration of Animal Studies Based on Duration of Clinical
Use Section 7. Substances Generally Recognized as Safe
Table 28.2 Substances Generally Recognized as Safe (GRAS) Section 8. Glossary References
The following information is designed as an introductory guide to regulatory toxicology for a toxicologist in the pharmaceutical industry. The section on FDA organization will be helpful when trying to determine the particular part of FDA with which to interact. Some of the more commonly required topics are also addressed, e.g., NDA Format, User Fees, Pregnancy Categories, Guidelines for Animal Toxicity Testing, and GRAS Substances.
