Regulations.gov document
Guidance for Industry on Interpreting Sameness of Monoclonal Antibody Products Under the…
Notice · FDA-1999-D-0178 · posted Apr 23, 2014
Key facts
| Document ID | FDA-1999-D-0178-0009 |
|---|---|
| Title | Guidance for Industry on Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-1999-D-0178 |
| Posted | Apr 23, 2014 |
| Federal Register citation | 79 FR 22693 |
| FR document number | 2014-09220 |
| Comment period opens | Apr 23, 2014 |
| Effective date | Apr 23, 2014 |
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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