On December 18, 2016, the FDA will require all submissions of NDAs, ANDAs, certain BLAs and INDs, as well as subsequent submissions, amendments, supplements, and reports to be filed in STDM and SEND electronic formats.
The FDA (and eventually, regulatory agencies from around the world) will require data sent to them to be in CDISC standards. This paper explains the various standards that companies will need to utilize for submissions to regulatory agencies.
Why does this deadline matter?
Non-compliance can result in Failure to File or Failure to Receive. Adhering to three main requirements is the key to success in meeting the requirements of this mandate:
- Exchange in format standards: PDF, XPT, XML
- Study data standards: SDTM, SEND
- Controlled terminology: CDISC Controlled terminology, MedDRA, WHO Drug