Resources Needed for Risk Assessment
Part of the Health Systems Research book series (HEALTH)
This paper addresses resource needs for assessing the risk of pharmaceutical products. My remarks are largely confined to the postapproval aspects of risk assessment and are based on lessons learned during the 6 years I have been charged with postmarketing safety monitoring at the Food and Drug Administration (FDA). There are three ingredients essential for providing resources for risk assessment:
KeywordsRisk Assessment Topical Minoxidil Adverse Drug Reaction Monitoring Epidemiologic Technique Intercontinental Medical Statistics
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
Unable to display preview. Download preview PDF.
- 1.Faich GA, Lawson DH, Tilson HH, Walker A (1987) Clinical trials are not enough: drug development and pharmacoepidemiology. J Clin Res Drug Dev 1 (1):75–78Google Scholar
- 3.Sills JM, Faich GA, Milstien JB, Turner WM (1986) Postmarketing reporting of ADR’s to FDA: an overview of the 1985 FDA guideline. Drug Inf J 20 (2):150–156Google Scholar
- 8.Food and Drug Administration (1987) Studies of reported adverse effects of marketed drugs; availability of grant; request for applications. Federal Register 52 July 10:26086–26088Google Scholar
© Springer-Verlag Berlin Heidelberg 1991