Standard for Exchange of Nonclinical Data (SEND)
SEND is the electronic formatting requirement for submission of study data contained in certain Investigational New Drug (IND), New Drug Application (NDA), Abbreviated NDA application (ANDA), and Biologic License Applications (BLA) to the US FDA.
Importance of SEND
SEND readiness at Eurofins Advinus
- SEND is being used by the FDA to analyze data in study submissions
- Rapid access to large amount of data, faster FDA review and therefore faster time to market
- Uses controlled terminologies
- Standardized formats
- Enhanced data review
- Eliminates data entry by agency
- Enables data warehousing, analysis and visualization
- Noncompliance can result in a refusal to file from the FDA and submission delays.
- We are using Instem Submit SEND software to produce SEND data since March 2018
- Have successfully submitted SEND data for clients for IND, NDA and ANDA studies