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Guidance Documents/Guidance-Document/E2BM Data Elements for Transmission Of Individual Case Safety Reports

E2BM Data Elements for Transmission Of Individual Case Safety Reports

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

April 4, 2002

April 20, 2020

Center for Drug Evaluation and Research

ee70791b-0ecd-42b4-94aa-27632314cfa8

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