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Office of Combination Products

Home Office of Combination Products
FDA Guidances

Draft Guidance for Preparing a Pre-Request for Designation

By Sharif AhmedCombination Product
On February 15, FDA issued a draft guidance on How to Prepare a Pre-Request for Designation (Pre-RFD). This guidance is intended to assist sponsors in obtaining a preliminary assessment from the FDA through the Pre-RFD process. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP)…
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