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

ICR 202110-0910-003 · OMB 0910-0230 · Object 115365201.

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File Typeapplication/octet-stream
File TitleProviding Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for
SubjectProviding Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for
AuthorFDA/CDER/Lars Michael Flores
File Modified2020-08-01
File Created2016-11-23
Conversion Statecomplete