Zdrowie i gospodarka · 4/18/2011
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.