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Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for
ICR 202303-0910-017 · OMB 0910-0230 · Object 130188401.
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Document Metadata
| File Type | application/octet-stream |
|---|---|
| File Title | Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for |
| Subject | Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for |
| Author | FDA/CDER/Lars Michael Flores |
| File Modified | 2020-07-25 |
| File Created | 2016-11-23 |
| Conversion State | complete |