Table of Contents
Labeling Products for Use in Pregnancy: Moving Forward
Objectives for Today
Labeling 101
Label Guides Use of Product
I. Pregnancy Section of Label
Experience Applying Categories
Greatest Challenge Area of medicine where the most certainty is desired, but there is the least data.
II. Pregnancy Labeling Taskforce
Task A: Examine Current Regulations: Part 15 Public Hearing
Current System: Positive Aspects
Current System: Sample Criticisms
“Take Home Message”
II. Developing a New Model
Model Label Format
December 2000 Where are we now?
Why Does it Take Years?
III. Broader Needs of Pregnancy Labeling
1. FDA Expertise
2. Improving Data: Safety
Safety Data in the Future
3. Data: Lactation
FDA and Lactation
4. Data: Clinical Pharmacology
Pregnancy Changes Physiology and Alters Drug PK
Contrast of Altered Physiologies
FDA and Pregnancy PK/PD Current Status
Where We Need To Go: Collaboration and Facilitation
Collaboration (continued)
Summary |
Author: Sandra L. Kweder, M.D. FDA, Office of Drug Evaluation IV
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