Good pharmacovigilance practices and pharmacoepidemiologic assessment
by FDA Center for Drug Evaluation and Research
This white paper by the Center for Drug Evaluation and Research (CDER) provides guidance on good pharmacovigilance practices and the pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products (excluding blood and blood components). Specifically, this white paper provides guidance on safety signal identification and interpretation, pharmacoepidemiologic assessment and pharmacovigilance plan development. It uses the term pharmacovigilance to mean all scientific and data gathering activities relating to the detection, assessment, and understanding of adverse events.
| Published: | 2005 |
| Format: | |
| Length: | 23 pages |
| Type: | White paper |
| Language: | English |
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