Regulations.gov document
Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for…
Notice · FDA-2013-D-1464 · posted Dec 5, 2013
Key facts
| Document ID | FDA-2013-D-1464-0001 |
|---|---|
| Title | Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2013-D-1464 |
| Posted | Dec 5, 2013 |
| Federal Register citation | 78 FR 73199 |
| FR document number | 2013-29081 |
| Comment period opens | Dec 5, 2013 |
| Comments due | Mar 6, 2014 |
| Effective date | Dec 5, 2013 |
At a glance
- 1–9 Pages
- No Open for comment
- 10–99 Public comments on this docket
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