21 CFR 558.15 “Studies”: A brief history

1/24/02


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Table of Contents

21 CFR 558.15 “Studies”: A brief history

Situation in the 1960s

In the 1970s...

Task force findings:

Task force conclusions:

Title 21 CFR Part 558.15

21 CFR 558.15 (b) (1) - (b) (3)

21 CFR 558.15 by July 19, 1973...

21 CFR 558.15 by October 17, 1973...

21 CFR 558.15 by March 4, 1974...

21 CFR 558.15 by April 20, 1974...

21 CFR 558.15 by April 20, 1975...

21 CFR 558.15 by September 5, 1975...

21 CFR 558.15 Study design

21 CFR 558.15 Study design (cont’d)

Parameters examined were:

FDA guidance on 558.15 studies

Integrity measurements evaluated:

Integrity measurements evaluated (cont’d)

RESULTS (TOTALS reflective of final decision)

Studies REJECTED because...

Studies REJECTED because...(cont’d)

Problems identified following retrospective analysis:

Summary

Author: Jeffrey M. Gilbert, Ph.D.