{"id":12916,"date":"2021-03-24T07:37:00","date_gmt":"2021-03-24T12:37:00","guid":{"rendered":"https:\/\/en.ennov.com\/?p=12916"},"modified":"2021-10-25T03:32:33","modified_gmt":"2021-10-25T08:32:33","slug":"fda-updates-ectd-documents","status":"publish","type":"post","link":"https:\/\/dqdev.co\/ennov\/blog\/regulatory-blog\/fda-updates-ectd-documents\/","title":{"rendered":"FDA News: FDA Updates Various eCTD Documents"},"content":{"rendered":"\n

Recently, the FDA updated a number of documents related to eCTD.  These changes are summarized in the eCTD Submission Standards<\/a> document, which provides a consolidated change history and links to supporting documents.<\/h2>\n\n\n\n

Support for Modeling and Simulation.<\/strong>  <\/h2>\n\n\n\n

This is an interesting area which is evolving rapidly.  FDA has signaled support for supporting M&S to accelerate approvals of drug and biological products. In 2018, the FDA started a Model-Informed Drug Development (MIDD) Pilot Program.  This provided sponsors with the opportunity to discuss MIDD approaches for development programs.  According to an article published by DIA<\/a>, <\/p>\n\n\n\n

\u201cPoints in the drug development and review process where the agency sees the potential of M&S include exploratory development and dose finding; evaluation of a sponsor\u2019s proposed late-phase protocol, study design, and analysis plan during the IND phase; evaluation of a completed trial submitted during the NDA phase; and postapproval \u201cwhat if\u201d benefit\/risk scenario assessments.\u201d<\/p>\n\n\n\n

To support this, the FDA now accepts a variety of Modeling & Simulation file types: .cmpx, cmpz, .wksx, .wksz, ,lbrx, .lbrz, .mdb, .pbk, .opd, .psd, .spd .c, .cpp, .m, .mat, .rmd, .phxproj, .py, .jl, .cas, .dat.  Details appear in Specifications for File Format Types Using eCTD Specification.<\/a><\/em><\/p>\n\n\n\n

Updates to eCTD Validation Criteria<\/strong><\/h2>\n\n\n\n

 The Validation Criteria includes new and updated validation checks:<\/p>\n\n\n\n

\u201cUpdate to the effective date of the eCTD Validation Criteria 1734, 1735, 1736 (see Technical Rejection Criteria for Study Data), 1737, and 1789, and new eCTD Validations (1551, 1553, 1554) which support the Promotional Labeling and Advertising Materials Guidance\u201d<\/p>\n\n\n\n

Of these, the most interesting are new items related to promotional material submissions.<\/p>\n\n\n\n