It’s here! CDER and CBER will only accept eCTD for new NDAs, ANDAs, and BLAs.

In just a few days, May 5, 2017, the FDA will only accept eCTD formatted submissions for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs). Passing this milestone represents a substantive step forward in the agencies move to adopting a common submission intake process.
While industry has been aware of this upcoming deadline for some time many are still left searching for ways to comply with the requirement while meeting planned milestones. Fortunately, many established regulatory support firms exist to alleviate the infrastructure and expertise hurdles that companies may face when evaluating eCTD systems.
Regxia Inc. has been using its chosen e-publishing software for the past 10 years and we are happy to say that recently the FDA also adopted the same system. Since first offering this service, Regxia has compiled, validated and submitted over 5000 e-submissions (base submissions and lifecycle sequences) to Health Canada and the US FDA. The recent migration of both agencies to the same e-software allows the reviewers to be capable and comfortable navigating our client’s submissions during review.
While the May 2017 deadline only covers marketing applications, the FDA has committed to requiring all new Drug Master Files (DMFs) and Commercial Investigational New Drug Applications (INDs) be in eCTD format starting in May 2018.
Regxia’s expertise in compiling both clinical and marketing applications in tandem with our e-publishing services positions us as a key outsourced asset for companies of any size who require support in meeting the FDA’s e-requirements.
We look forward to assisting more potential clients with their Regulatory and e-Publication needs.
The FDA announcement can be found here:
https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm153574.htm

About Regxia Inc.
Regxia Inc. is a unique scientific and regulatory consulting firm serving the pharmaceutical and biotech industries. Regxia focuses on fostering long-term client relationships based on trust, reliability and common values. Regxia offers a full range of Regulatory Services to support client products at all stages of development, from concept to launch and through its lifecycle. Regxia has direct experience with pharmaceuticals, biologics, and medical devices in all therapeutic areas. The in-depth awareness and understanding of global regulatory and “e” requirements and regulatory strategy that Regxia’s staff possess allows them to minimize the time to market for their clients. Learn more at www.regxia.com

Contact: Cameron McGregor, Manager Business Development – mcgregor@regxia.com

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