FDA has updated the guideline for module 1 specifications version from v2.3 to v2.4.
Summary of Changes for Version 2.4
Added eCTD Submission Type ‘REMS Supplement’. The updated sections are listed below:
- ‘REMS Supplement’ added in Submission Types and Description of Use Table
- ‘REMS Supplement’ added as valid submission type for PAS and CBE-30 in Supplement-Effective-Date-Types and Descriptions of Use Table
- ‘REMS Supplement’ added as valid submission type for submission sub-types of ‘application’, ‘amendment’, and ‘resubmission’ in Submission Sub-Types and Descriptions of Use Table
Note – This Updation is in draft stage only means not implemented yet.
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