FDA SEND 3.1 Mandate Goes Into Effect
Scope of SEND Widens to Include Support for Cardiovascular and Respiratory Studies
CONSHOHOCKEN, PA – March 15, 2019 - - Instem, a leading provider of IT solutions to the global life sciences market, announced today that the next major milestone in the FDA’s adoption of SEND (Standard for Exchange of Nonclinical Data) came into force today.
Studies starting after today, March 15, 2019, which are in support of an NDA or BLA application to FDA, need to be submitted in SEND 3.1 format. The move from SEND 3.0 to SEND 3.1 sees the scope of SEND widen to now include support for Cardiovascular and Respiratory studies. SEND 3.1 also provides certain improvements to the standard, particularly around the nominal dates for report grouping and also providing additional variables for better describing Microscopic findings.
“This next milestone shows FDA’s continued adoption of the developing SEND Standard and means that more study data can now be submitted to the agency. In anticipation of this, we have seen our clients implement the latest version of our submit™ suite which supports SEND 3.1,” stated Marc Ellison, Director, SEND Solutions at Instem.
In-progress studies that started prior to March 15th may remain in SEND 3.0 format, however, failure to comply with the SEND 3.1 Mandate for studies starting after today’s date can result in the FDA’s technical rejection or refusal to file a submission.
Instem has unparalleled experience in helping companies to prepare for SEND, and its software and outsourced services are the most widely adopted in the industry at over 80 client sites across 15 countries. Instem’s team of SEND experts has helped to organize, educate and guide clients to becoming SEND-enabled, identifying specific approaches that maximize the benefits of SEND, while ensuring regulatory compliance.
Instem is a global provider of leading software solutions and services that are helping over 500 clients bring their life enhancing products to market faster. We enable clients in the life sciences to more efficiently collect, analyze, report and submit high quality regulatory data, while maintaining compliance for their products around the world.
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 supports its global roster of clients through offices in the United States, United Kingdom, France, Japan, China and India.
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