We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Drugmakers, who have been waiting quite some time for the FDA to provide them with the agency’s thinking on the issue of risk management, got at least some relief earlier this month. The agency issued three draft guidances — titled “Premarketing Risk Assessment,” “Development and Use of Risk Minimization Action Plans” and “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment” — that address many of the industry’s questions about how to navigate the tricky regulatory waters of risk management. While the documents may not be as complete as some in the industry would have liked them to be, they do describe safety issues throughout a product’s life cycle, including development, review, approval and market availability. In addition to the three guidances, the FDA also has released a pharmacovigilance guidance drafted by the International Conference on Harmonisation that outlines ways drugmakers can summarize the identified risks of a drug, the potential for unidentified risks, as well as possible risks for specific populations and situations that have not been studied preapproval. Taken together, the four documents represent a regulatory roadmap of the FDA’s latest thinking on the issue of risk management.