In the United States, in vitro diagnostic products are classified and reviewed under two separate FDA Centers, depending on whether the product is intended to be used to diagnose a condition, predict if a particular treatment will be effective or monitor the effect of a treatment, or if it is intended to be used in the testing of transfusable blood or cellular products.
In this audio conference we highlight the differences in the two product review processes between the Centers and provide insight into their expectations regarding information required in submissions and following product approval. Recent Guidance Documents issued by FDA are discussed.
Biologic vs. Non-biologic: Current FDA Thinking on IVDs was presented by Ann Quinlan-Smith & Pamela J. Vaughan, President & Senior Principal Consultant, with Alquest, Inc. and aired on 2008-02-28. For more details about purchasing a download, please visit our site www.fxconferences.com
