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Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)

ICR 202405-0910-001 · OMB 0910-0230 · Object 144772500.

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Document Metadata
File Typeapplication/octet-stream
File TitleProviding Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)
SubjectPostmarketing, Periodic, Safety Reports, ICH, E2C(R2), Format, Periodic, Benefit-Risk, Evaluation, Report
AuthorFDA CDER CBER
File Modified2024-12-19
File Created2024-12-19
Conversion Statefailed_conversion