Regulations.gov document
Reference 1. "Detailed Guidance on the Collection, Verification and Presentation of…
Supporting & Related Material · FDA-2000-N-0108 · posted Sep 29, 2010
Key facts
| Document ID | FDA-2000-N-0108-0073 |
|---|---|
| Title | Reference 1. "Detailed Guidance on the Collection, Verification and Presentation of Adverse Reaction Reports Arising From Clinical Trials on Medicinal Products for Human Use" [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule] |
| Document type | Supporting & Related Material |
| Subtype | BKG-Background Material |
| Agency | FDA |
| Docket | FDA-2000-N-0108 |
| Posted | Sep 29, 2010 |
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