The Food and Drug Administration has issued three final guidance documents, which it claims will help develop new ways and improve methods to assess and monitor the risks associated with drugs and biological products in clinical development and general use.
The agency says that the guidelines form part of an ongoing effort to minimise the risks associated with medicines. “Continuing to improve the way safety is assessed and monitored will lead to the earlier identification of safety problems and enable a more proactive approach to minimising these risks,” said Dr Steven Galson, acting director of the agency’s Centre for Drug Evaluation and Research.
The guidelines give advice on pre-market risk assessment and measures companies might consider throughout all stages of clinical development of products, and also suggest ways the pharmaceutical industry can address specific risk-related goals and objectives as well as minimising the risks of drug and biological products. Furthermore, the guidance recommends reporting and analytical practices to monitor the safety concerns and risk of medical products in general use.