Zdrowie i gospodarka · 5.08.2020
Pilot Program for Request for Designation and Pre-Request for Designation Electronic Submissions
The Office of Combination Products (OCP) in the Food and Drug Administration (FDA) is soliciting applications from members of the public interested in participating in a voluntary pilot program to help OCP evaluate a potential new electronic submissions process for Requests for Designation (RFD) and Pre-RFD. This RFD and Pre-RFD electronic submission process is intended to improve efficiency and completeness of RFD and Pre-RFD submissions. OCP plans to accept up to nine participants for the pilot program. The pilot program is intended to provide OCP input to inform this evaluation.