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Zdrowie i gospodarka · 18.04.2011

Guidance for Industry on How To Write a Request for Designation; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "How to Write a Request for Designation (RFD)." This guidance is intended to clarify the type of information the Office of Combination Products (OCP) recommends that a sponsor include in a Request for Designation (RFD). This final guidance supersedes the previous RFD guidance document issued August 2005.

Source: Federal Register — Health and Human ServicesOpen original release →