Regulations.gov document
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an…
Notice · FDA-2013-D-1464 · posted Aug 23, 2021
Key facts
| Document ID | FDA-2013-D-1464-0016 |
|---|---|
| Title | Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Draft Guidance for Industry; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2013-D-1464 |
| Posted | Aug 23, 2021 |
| Federal Register citation | 86 FR 47117 |
| FR document number | 2021-18073 |
| Comment period opens | Aug 23, 2021 |
| Comments due | Oct 23, 2021 |
At a glance
- 1–9 Pages
- No Open for comment
- 10–99 Public comments on this docket
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Regulations.gov documents
Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.
Source: Regulations.gov (U.S. General Services Administration eRulemaking Program) · Source date: