Tag Archives: PreRequest

FDA Issues Draft Guidance for Preparing a Pre-Request for Designation

By Allyson B. Mullen — On February 15, FDA’s Office of Combination Products (OCP) announced the draft guidance, “How to Prepare a Pre-Request for Designation (Pre-RFD).” Don’t let the name fool you though.  Unlike the similarly named Pre-Submission, a Pre-RFD … Continue reading

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