FDAs Premarketing Risk Assessment Guidance

Several factors influence the determination of the appropriate size of a preapproval safety database for a new investigational drug  

The FDA recommends that sponsors address the potential for serious adverse effects in various categories for all new small-molecule drugs, including the following  

The meaning of the word address in this context varies with circumstance. For example, for a drug that is intended to be applied topically, if it has been demonstrated that the drug has no systemic bioavailabifity, systemic toxicities would not be of concern, and addressing this issue could therefore be done in relatively less detail. 

Certain adverse events, e.g those leading to discontinuation, death, and other serious adverse events, require narrative summaries to be written and submitted. These narratives should not simply repeat in sentence format the information that was presented in the body of the clinical study report in numerical format. Rather, the narratives should permit an adequate understanding of the nature of each adverse event by providing a complete synthesis of all available clinical data and an informed discussion of the case (FDA 2005, p. 26). Useful components in a narrative include  

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Source Guidance for Industry Premarketing Risk Assessment, May 2004, U.S. Food and Drug Administration, http//www.fda.gov/cber/guidelines.htm accessed May 20, 2004. 

Food and Drug Administration. Guidance for industry—Premarketing risk assessment, http / / www.fda. gov/ downloads/ Drugs/GuidanceComplianceRegulatory Information/Guidances/UGM072002.pdf, 2005. Accessed January 10,2014. 

FDA (2005) Guidance for Industry. Premarketing risk assessment. Available at http //www.fda. gov/downloads/regulatoryinformation/guidances/ucml26958.pdf. Accessed 24 Nov 2015... 

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