All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2016-D-1280
International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS)
Documents
5
Comments
0
Key Dates
Comment Period OpensJun 23, 2016
Comment Period ClosesOct 2, 2026
Documents
Keywords
2015-286
International Conference on Harmonisation
Electronic Transmission of Postmarket
Individual Case Safety Reports for Drugs and
Biologics, Excluding Vaccines
Availability of FDA Regional Implementation
Specifications for ICH E2B(R3)
Reporting to the FDA Adverse Event Reporting
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