FDA SEND Mandate for IND Submissions Goes Into Effect
CDISC SEND Standard Now Applies to all IND Submissions to FDA
CONSHOHOCKEN, PA - December 18, 2017 - Instem, a leading provider of IT solutions to the global life sciences market, announced today that the next major milestone in FDA’s adoption of SEND (Standard for Exchange of Nonclinical Data) came into force over the weekend, mandating that IND submissions now fall under the requirement to include SEND datasets. This requirement is for SEND 3.0 and means that the same requirement which has been in place for NDAs, now applies to new INDs that start after December 17, 2017.
The introduction of SEND for both regulatory submission and the electronic exchange of toxicology data is having a significant impact on the industry. Each organization in the pharmaceutical early development value chain is now touched by the implementation of this standard and will need to make changes to their systems and working practices.
Failure to comply with the SEND Mandate 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 tools and outsourced SEND 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-Ready, identifying specific approaches that maximize the benefits of SEND, while ensuring regulatory compliance.
For more information about Instem’s submit™-tools & outsourcing services for the creation, management, visualization and pre-submission analysis of SEND datasets click here.
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.
Gary Mitchell (US HQ)
Julie Jones (UK HQ)
Tel: +44 (0) 1785 825600