FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Current Version of MedDRA Recommended for Electronic Submissions

Sept. 5, 2017
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Applicants for FDA drug approvals should consult the current version of the Medical Dictionary for Regulatory Activities (MedDRA) for the format to use for computer coding of study data included in electronic submissions, the agency said.

Applicants may follow the format from earlier versions of MedDRA — through version 8 — for data studies that start by March 15, 2019, but not after that date, the agency said.

The FDA issued final guidance on coding in electronic submissions on Dec. 17, 2014, and the requirement to follow MedDRA went into effect on Dec. 17, 2016.

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