FDA SEND Mandate for Regulatory Submissions Now In Force
Study Submissions Must Adhere to FDA-Supported Formats
CONSHOHOCKEN, PA – December 19, 2016 - The FDA SEND Mandate for providing regulatory submissions in electronic format is now in force. The FDA’s eStudy Guidance, published on December 18, 2014, mandated the provision of nonclinical submission data using the CDISC SEND standard with effect from December 17, 2016.
This means that all organizations must now use the appropriate FDA-supported standards, formats and terminologies specified in the FDA Data Standards Catalog for NDA, ANDA, and certain BLA submissions.
Failure to comply with the Mandate can result in the FDA’s technical rejection or refusal to file a submission, therefore, it is vitally important that organizations are SEND compliant.
Instem has been heavily involved with the development of SEND since the beginning and has a wealth of unparalleled experience in supporting companies to prepare for the standard. Instem has helped to organize, educate and guide numerous clients to becoming SEND-Ready, identifying specific approaches that maximize the benefits of SEND, while ensuring regulatory compliance.
In 2005 Instem developed submit™, the first commercially available SEND software solution on the market. Submit creates datasets from any electronic source, it then manages SEND datasets throughout their entire lifecycle including the ability to QC Review and perform advanced single and multi-study data visualizations and analyses.
Instem is also catering to the needs of its clients by providing a comprehensive range of outsourced SEND Services that meet organizations at any stage of SEND Readiness. Instem acts as an extension of their clients, providing internal and external stakeholders with dependable services including Initial SEND Training, SENDReady™ Consulting, Study Conversion Services, SEND dataset Verifications and more.
The submit solution for SEND is uniquely meeting the very wide range of demands that span the needs of the largest multi-national pharmaceutical organizations and CROs, to the smallest organizations and their advisors.
The submit suite of software and outsourced services are now the most widely adopted in the market, supporting over 47 client sites across 15 countries.
Free Industry Resources
Instem has produced an extensive library of informative SEND video resources from “Becoming SEND-Ready” and “Creating Submission-Ready SEND Datasets” through to “Advanced SEND Data Visualization & Analysis”. These resources are available free of charge by request.
Instem is a leading supplier of IT applications and services to the early development healthcare market delivering compelling solutions for data collection, analysis and regulatory submissions management. Instem solutions are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making leading to safer, more effective products.
Instem’s portfolio of software solutions and consulting services increases client productivity by enhancing product development processes while offering the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Instem supports over 500 clients through offices in the United States, United Kingdom, France, Japan, China and India.
Gary Mitchell (US HQ)
Julie Jones (UK HQ)
Tel: +44 (0) 1785 825600