Table of Contents
State of the U.S. Drug Regulatory System
Purpose of this meeting:
Agenda
U.S. Drug Regulatory System
Components of System
Components of System (cont.)
Expectations for the System
Expectations for the System (cont.)
Expectations for the System (cont.)
Drug Regulatory System: Processes
Drug Regulatory System: Processes (cont.)
Drug Regulatory System: Processes
Drug Regulatory System: Essential Supporting Activities
Essential Supporting Activities
Essential Supporting Activities:
Essential Supporting Activities:
FDA Drug Regulatory Program: 1998 Resources*
Factors Affecting Resource Distribution
Application Review: IND Process
IND Process: Standards
Investigational New Drug Process: Issues
New Drug Review: Performance
New Drug Review: Standards
New Drug Review: Issues
Application Review: Generic Drugs
Generic Drug Review: Issues
Application Review: Supplemental NDA’s (New Uses)
Product Quality Assurance: Performance
Product Quality Assurance: Issues
Product Quality Assurance: Issues (cont.)
Surveillance/Compliance
Surveillance: Drug Marketing and Advertising: Issues
Surveillance: Human Subject Protection
Safety of Marketed Drugs
Safety of Marketed Drugs (cont.)
Communications
Summary |
