You are currently viewing archive.bio.org. Head to our home page to check out our fresh new look!

BIO Submits Comments to CDISC on SEND Implementation Guide

<p>
The Biotechnology Industry Organization (BIO) thanks the Clinical Data Interchange Standards Consortium (CDSIC) for the opportunity to submit comments on its Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) Version 3.1.</p>

 The Biotechnology Industry Organization (BIO) thanks the Clinical Data Interchange Standards Consortium (CDSIC) for the opportunity to submit comments on its Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) Version 3.1.

BIO appreciates the opportunity to review and comment on this version of the SENDIG. BIO’s member companies are committed to transitioning to an all-electronic FDA review environment and supports submitting all Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs), in electronic format as phased-in under PDUFA V. The continuing implementation of the SEND standard will play an important role in that process over the coming years.