Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 91

The FDA created multiple action plans to address the requirements of the law. In particular, FDA issued a “Prescription Drug User Fee Act Five-Year Plan” with each sequential renewal of PDUFA. Each plan includes steps to address the requirements in the legislation. Details and milestones are posted on the FDA website.

Other FDA initiatives under way are briefly mentioned below. The landscape changes frequently and FDA’ s website should be checked periodically for updates and new initiatives.