Abstract
Get full access to this article
View all access options for this article.
References
1.
21 CFR 310.305.
2.
21 CFR 314.80.
3.
52 Stat. 1040 (The Food, Drug, and Cosmetic Act, June 25, 1938 .).
4.Problem Solving I. Literature, Foreign, Study, Death, Overdose.
FDA , Rockville, MD , May 16, 1988 .
5.
(Draft) Guideline for Postmarketing Reporting of Adverse Drug Reactions (Docket No. 85 D-0249), FDA , Rockville, MD , August 23, 1985 .