Regulations.gov document
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA…
Other · FDA-2013-D-1464 · posted Aug 23, 2021
Key facts
| Document ID | FDA-2013-D-1464-0017 |
|---|---|
| Title | Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry DRAFT GUIDANCE |
| Document type | Other |
| Subtype | Guidance |
| Agency | FDA |
| Docket | FDA-2013-D-1464 |
| Posted | Aug 23, 2021 |
| Comment period opens | Aug 23, 2021 |
At a glance
- 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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