Regulations.gov document
Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing…
Notice · FDA-2005-D-0208 · posted Jul 17, 2008
Key facts
| Document ID | FDA-2005-D-0208-0003 |
|---|---|
| Title | Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency; Availability |
| Document type | Notice |
| Subtype | NAD-Notice of Availability of Data |
| Agency | FDA |
| Docket | FDA-2005-D-0208 |
| Posted | Jul 17, 2008 |
| Federal Register citation | 73 FR 41087 |
| FR document number | E8-16395 |
| Comment period opens | Jul 17, 2008 |
| Effective date | Jul 17, 2008 |
At a glance
- 1–9 Pages
- 1–9 Public comments on this docket
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