Regulations.gov document
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission…
Rule · FDA-2008-N-0334 · posted May 27, 2015
Key facts
| Document ID | FDA-2008-N-0334-0015 |
|---|---|
| Title | Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products |
| Document type | Rule |
| Subtype | Final Rule |
| Agency | FDA |
| Docket | FDA-2008-N-0334 |
| Posted | May 27, 2015 |
| Federal Register citation | FR 80 30151 |
| FR document number | 2015-12753 |
| CFR | 21 CFR Parts 310, 314, 329, and 600 |
| Comment period opens | May 27, 2015 |
| Effective date | May 27, 2015 |
At a glance
- 1–9 Pages
- 1–9 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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