Clinical and non-clinical data
must be submitted in conformance to FDA Data Standards Catalog for
studies starting after December 17, 2016 for NDAs, BLAs, ANDAs (for INDs, the
requirement starts after Dec. 17, 2017).
The FDA may refuse to file (RTF)
or refuse to receive (RTR), an electronic submission that does not comply with
this requirement. For more information, please click here!
See the FDA notice on study data
standards requirements: Study
Data Standards: What You Need to Know
Asphalion has extensive
experience in electronic submissions using the standards, formats, and
terminologies specified by FDA.
If you need any support to
comply with FDA requirements, please contact us: info@asphalion.com
