Table of Contents
Welcome
Today’s Agenda
Open Public Hearing
Agenda: Guidance Documents
What is a Guidance?
Pregnancy Labeling/Pregnancy Registries
Pregnancy Registries and DRUDP
Infertility Therapies
Morning Agenda
Labeling Products for Use in Pregnancy: Past, Present and New Directions
Objectives for Today
Labeling 101
I. Pregnancy Section of Label
“Pregnancy Categories”
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
1. Current System: Positive Aspects
2. Current System: Sample Criticisms
“Take Home Messages”
Task B: Make Recommendations for Changes in Labeling
Labeling
Process
Model Pregnancy Labeling Format
Summary Risk Assessment
Clinical Considerations
Discussion of Data
Pregnancy Labeling Advisory Committee June 3, 1999 Chair: Michael Greene, MD
Summary of Committee Meeting
Summary
Task C: Consider Broader Needs of Pregnancy Labeling
1. FDA Expertise
2. Improving Data
3. Other Possibilities
Summary
PPT Slide
Industry Guidance: Design and Conduct of Pregnancy Registries (Establishing Pregnancy Registries)
Purpose of Pregnancy Registry Guidance
Purpose of Pregnancy Registries
Problem: Lack of Human Data
Problem: Lack of Human Data
Limitations of Current Methods for Assessing Risk
Pregnancy Registries
Pregnancy Registries
When are Pregnancy Registries Needed?
When are Pregnancy Registries Needed?
Timing and Scope of Pregnancy Registries
Design Considerations in Pregnancy Registries
Design Considerations in Pregnancy Registries
Design Considerations in Pregnancy Registries
Design Considerations in Pregnancy Registries
Design Considerations in Pregnancy Registries
Design Considerations in Pregnancy Registries
Design Considerations in Pregnancy Registries
Design Considerations in Pregnancy Registries
Data Analysis Plan
Public Comments
Assisted Reproductive Technologies (ART): Applying the use of Pregnancy Registries in DRUDP
ART: Definition
ART: Commonly Accepted Procedures
ART: Commonly Used Procedures
ART: Commonly Used Procedures
ART: Commonly Used Procedures
ART: Commonly Used Procedures
FDA Centers Regulating ART
ART: Commonly Used Drugs
Selected IVF Registries and Surveys
Selected Registry Data: SART
Congenital Malformations Occuring in ART Trials: Selected Examples
Open Public Hearing
Questions for the Committee
Questions for the Committee
Questions for the Committee
Questions for the Committee
Afternoon Agenda
FDA Guidance Documents Related to Estrogen-Containing Drug Products: Current Issues and Status
Goals
Description of Guidance Documents Related to E-containing Drug Products
Guidance Documents for Discussion Today
Estrogen Class Labeling Guidance Document
Estrogen Class Labeling: Background
Estrogen Class Labeling: Background
Estrogen Class Labeling: Background
Proposed Changes in Guidance Document
Proposed Changes
Proposed Changes
Proposed Changes: Indications
Proposed Changes
ERT/HRT Drug Development Guidance Document
Background
Proposed Revisions
Section 1: Trials of E-Containing Drug Products (ERT Trials)
ERT Trials
ERT Trials
VMS Indication: Number and Design of Trials
VMS Indication: Inclusion Criteria
VMS Indication: Inclusion Criteria
VMS Indication: Inclusion Criteria
VMS Indication: Primary Efficacy Endpoints
VMS Indication: Monitoring and Special Considerations
Section 2: Trials of Combination Estrogen-Progestin Products: HRT or Hyperplasia Prevention Trials
HRT/Hyperplasia Prevention Trials
HRT/Hyperplasia Prevention Trials: Inclusion Criteria
HRT/Hyperplasia Prevention Trials: Primary Efficacy Endpoint
HRT/Hyperplasia Prevention Trials: Monitoring
HRT/Hyperplasia Prevention Trials: Other Considerations
HRT Drug Development Guidance Document: Osteoporosis Prevention
Other Guidance Documents in Process or Under Revision
Open Public Hearing
Questions for the Committee
Questions for the Committee
Questions for the Committee
Questions for the Committee
Questions for the Committee
Questions for the Committee
RHAdCom Subcommittees
Urologic Team and Subcommittee
Role of Urologic Team
Urology Team Members
Advisory Subcommittee Members
Partnering with the AC
Summation/Adjournment
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