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February 7, 2025

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility

Docket Number: FDA-2011-D-0720 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Implementation of ICH E2B(R3) The E2B(R3) document package comprises four materials. The […]
February 6, 2025

Novel Drug Approvals for 2025

What are “Novel” Drugs? “Novel” drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved […]