A SHIFT IN THE REGULATORY APPROACH

7/17/97


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Table of Contents

A SHIFT IN THE REGULATORY APPROACH

TOPICS FOR DISCUSSION

PPT Slide

FDA POLICIES ON OFF-LABEL USE

FDA POLICIES ON OFF-LABEL USE (con’t)

REASONS FOR FDA POLICIES ON OFF-LABEL USES:

CURRENT SITUATION IN MEDICAL PRACTICE

REASONS FOR SITUATION

CHANGING ENVIRONMENT

CHANGING ENVIRONMENT (con’t)

CHANGING ENVIRONMENT (con’t)

CHANGING ENVIRONMENT (con’t)

ACTIONS FDA HAS TAKEN

ACTIONS FDA HAS TAKEN (con’t)

FURTHER STEPS

ADDITIONAL ISSUES

SUMMARY

 Author: Janet Woodcock, M.D.

Home Page: http://www.fda.gov/cder/present/diamontreal/