Regulations.gov document
Final Rule re Investigational New Drug Safety Reporting Requirements for Human Drug and…
Rule · FDA-2000-N-0108 · posted Sep 29, 2010
Key facts
| Document ID | FDA-2000-N-0108-0071 |
|---|---|
| Title | Final Rule re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products: Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans |
| Document type | Rule |
| Subtype | Final Rule |
| Agency | FDA |
| Docket | FDA-2000-N-0108 |
| Posted | Sep 29, 2010 |
| FR document number | 2010-24296 |
| CFR | 21 CFR Parts 312 and 320 |
| Comment period opens | Sep 29, 2010 |
| Effective date | Sep 29, 2010 |
At a glance
- 10–99 Pages
- 10–99 Public comments on this docket
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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