Survey of Safety Information in the Investigator's Brochure: Inconsistencies and Recommendations.

A survey was undertaken to gain an understanding of current industry practices in the preparation of the safety information for the Investigator's Brochure (IB). Sixteen of a potential 25 respondents completed a survey (64% response rate). Five respondents represented pharmaceutical and biotech companies, and 11 were consultants or worked at contract research organizations for such companies.

Current requirements and emerging trends for labelling as a tool for communicating pharmacovigilance findings.

The labelling of prescription drugs is expected to ensure the safe use of medicines and effect changes in use if such changes are required by new safety information. However, withdrawal of drugs from the market and data about medication errors have demonstrated the limitations of labelling as a tool for risk management. Regulatory initiatives in many countries aim at increasing the usefulness and use of labelling by healthcare professionals and patients.