Regulations.gov document
Reference 13 - FDA, "Guidance for industry, M3 (R2) Nonclinical Safety Studies for the…
Supporting & Related Material · FDA-2006-N-0515 · posted Dec 5, 2014
Key facts
| Document ID | FDA-2006-N-0515-0082 |
|---|---|
| Title | Reference 13 - FDA, "Guidance for industry, M3 (R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals and the International Conference on Harmonisation S5 (R2) Guideline: Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility,". re Content and Format of Labeling for Human Prescription Drug |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2006-N-0515 |
| Posted | Dec 5, 2014 |
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