Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle; Public Workshop; Request for Comments

摘要

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled "Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle." The purpose of the public workshop is to solicit information and views from interested persons on research approaches and methods associated with the best ways to assess the public health benefit of collecting and reporting all adverse events (AEs). The input from this workshop will be used to publish a request for information to determine the types of outside organizations that would be interested in, and have the capability to conduct, the research described in this paragraph, followed by a request for proposal (RFP).