Table of Contents
FDA Standards Initiatives: An Overview
Overview
Why Standards?
Standards Development Organizations
FDA Data Council
Standards Development Process
Consolidate Health Informatics
Health Level Seven
ICH
CDISC
Standard Initiatives
Electronic Submissions
Electronic Submissions
Study Report
Structured Protocol
Structured Product Labeling
Individual Case Safety Report
Electronic MedWatch
Annotated ECG Waveform Data
Stability Data
Clinical and Animal Study Data
|
Author: LEVINR
Home Page: http://www.fda.gov/cder/regulatory/ersr/DIA2003.htm
Download presentation source
|