FDA has updated the guideline for module 1 specifications version from v2.3 to v2.4.
Summary of Changes for Version 2.4Added eCTD Submission Type ‘REMS Supplement’. The updated sections are listed below:
FDA has updated the guideline for module 1 specifications version from v2.3 to v2.4.
Summary of Changes for Version 2.4Added eCTD Submission Type ‘REMS Supplement’. The updated sections are listed below: