Regulations.gov document
06-Reference_M3(R2)-Nonclinical-Safety-Studies-for-the-Conduct-of-Human-Clinical-Trials RE…
Supporting & Related Material · FDA-2023-N-1585 · posted May 8, 2023
Key facts
| Document ID | FDA-2023-N-1585-0007 |
|---|---|
| Title | 06-Reference_M3(R2)-Nonclinical-Safety-Studies-for-the-Conduct-of-Human-Clinical-Trials RE Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket; Request for Comments |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2023-N-1585 |
| Posted | May 8, 2023 |
At a glance
- 10–99 Public comments on this docket
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