Post-Marketing Safety Surveillance Should Include Data Mining Techniques, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The advantages and limitations of data analysis from large adverse event databases are described in a draft guidance. Safety signals found through data mining should be put in the context of total patients exposed to the drug and considered for further investigation, FDA recommends.
You may also be interested in...
Risk Management Guidance Suggests Using Claims Data To Evaluate Safety Signals
Three FDA risk management final guidances recommend that sponsors collect a wide range of safety data during both the clinical trial and postmarketing periods of drug development. The agency suggests that sponsors hold discussions with FDA before settling on drug study designs or postmarketing activities.
Risk Management Guidance Suggests Using Claims Data To Evaluate Safety Signals
Three FDA risk management final guidances recommend that sponsors collect a wide range of safety data during both the clinical trial and postmarketing periods of drug development. The agency suggests that sponsors hold discussions with FDA before settling on drug study designs or postmarketing activities.
Drug Safety Final Guidances To Be Published In March, FDA Says
FDA will publish three final guidances related to prescription drug safety in March, FDA Office of New Drugs Deputy Director Sandra Kweder said