Zdrowie i gospodarka · 18/04/2011

FDA Releases Guidance on Writing a Request for Designation for Combination Products

The Food and Drug Administration (FDA) has made available a new guidance document, titled 'How to Write a Request for Designation (RFD),' which aims to clarify the necessary information for sponsors to include in a Request for Designation (RFD) for combination products, replacing the previous 2005 guidance document.