Description of Collaborative Activity: |
CDER’s Office of Business Informatics and Office of Medical Policy have partnered with NIH to build, and pilot, a cloud-based submission portal for research INDs. CDER is actively engaging with NIH to gain insight into the needs for this research IND submission portal. The portal will streamline and intuitively assist in submission of research INDs, digitize data that is currently captured in static PDFs in an electronic, structured format to alleviate the amount of PDF/paper submissions FDA receives thereby increasing FDA review efficiency, and create a dashboard interface for management of sponsor INDs |
