THE IMPACT OF FDA ISSUED WARNING LETTERS FOR GCP NON-COMPLIANCE ON THE DEVELOPMENT OF REGULATORY GUIDANCE DOCUMENTS

Abstract

The purpose of this study is to show that FDA guidance documents are drafted to further clarify the intent of the regulations. The development of guidance documents will impact the frequency of warning letter citations. Warning letters are issued for violations of the Food, Drug, and Cosmetic Act or the Code of Federal Regulations (CFR); guidance documents are written to clarify compliance. This study will examine if there is a correlation in type of warning letter citations to the development and publication of FDA guidance documents. Warning letters over a 15-year timeframe were analyzed. The data was analyzed for a strong relationship among citations and guidance occurrences using a two tailed significance level of 5%. The data analysis showed the issuing of GCP guidance documents does not correlate with trends in warning letter citations.