| Up
2004D-0459:
GUIDANCE FOR INDUSTRY ON PHARMACOKINETICS IN PREGNANCY STUDY DESIGN,
DATA ANALYSIS, AND IMPACT ON DOSING AND LABELING
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
|
| GDL1
|
| 10/29/2004
|
| 10/29/2004
|
| Federal
Government
|
| Guidance
|
|
|
|
|
|
|
| doc,
pdf
|
|
|
|
|
|
| Signature:
|
| Guidance
|
|
|
|
|
|
|
|
| NAD1
|
|
|
| 10/29/2004
|
| FDA
|
| FDA
|
| 11/01/2004
|
| 63402-63403
|
| 01/03/2005
|
| pdf
|
|
|
|
|
| Signature:
|
| SHUREN, JEFFREY
|
|
|
|
|
| EC1
|
| 12/16/2004
|
| 12/15/2004
|
| Drug Industry
|
| GlaxoSmithKline
|
|
|
|
|
|
|
| doc
|
|
|
|
|
|
|
| Signature:
|
| Stokley, M.S.P.H.,
Anne
|
|
|
| EMC1
|
| 12/21/2004
|
| 12/21/2004
|
| Drug Industry
|
| Merck & Co., Inc.
|
|
|
|
|
|
|
| text,
Attachment doc, pdf
|
|
|
|
|
|
|
| Signature:
|
| Lauren Hetrick
|
|
|
| C1
|
| 12/30/2004
|
| 12/29/2004
|
| Drug Industry
|
| AstraZeneca Pharmaceuticals,
LP
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Judith Molt
|
|
|
|
|
| C2
|
| 12/29/2004
|
| 12/28/2004
|
| Drug Industry
|
| Bristol-Myers Squibb
Company (BMS)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Joseph F. Lamendola,
PhD
|
|
|
|
|
| C3
|
| 12/27/2004
|
| 12/24/2004
|
| Drug Industry
|
| Abbott Laboratories
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Douglas L. Sporn
|
|
|
|
|
| C4
|
| 12/16/2004
|
| 12/15/2004
|
| Drug Industry
|
| GlaxoSmithKline (GSK)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Anne N. Stokley, MSPH
|
|
|
|
|
| C5
|
| 01/18/2005
|
| 01/18/2005
|
| Drug Industry
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Michael Garvin, PharmD
|
|
|
| C6
|
| 01/18/2005
|
| 01/14/2005
|
| Drug Industry
|
| Pfizer, Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Melissa S. Tassinari,
PhD., DABT
| |
|
|
|
| C7
|
| 02/23/2005
|
| 02/18/2005
|
| Drug Industry
|
| Eli Lilly and Company
(Lilly)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Thomas L. Copmann, PhD
| |
|
|
|
|
| |
Top | Up
Page last updated
March 22, 2005
kk |
