FDA Guidance on Drug, Device, Bioproduct Classification for RFDs Available
The Food and Drug Administration is announcing the availability of a guidance for industry entitled "How to Write a Request for Designation (RFD)," which supersedes the previous RFD guidance document issued in August 2005. The goal of the guidance…
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is to help a sponsor understand what information FDA needs to determine the regulatory identity or classification of a product as a drug, device, biological product, or combination product, and to assign the product to the appropriate Agency component for review and regulation.