Regulations.gov document
Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under…
Notice · FDA-1999-D-0178 · posted Apr 6, 2011
Key facts
| Document ID | FDA-1999-D-0178-0001 |
|---|---|
| Title | Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations; Availability |
| Document type | Notice |
| Subtype | Notice of Data Availability |
| Agency | FDA |
| Docket | FDA-1999-D-0178 |
| Posted | Apr 6, 2011 |
| Federal Register citation | 64 FR 40381 |
| FR document number | 99-18928 |
| Comment period opens | Apr 6, 2011 |
| Comments due | Oct 26, 1999 |
| Effective date | Jul 14, 1999 |
At a glance
- 1–9 Pages
- No Open for comment
- 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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