FDA PROPOSED DISCLOSURE RULE

3/29/01


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Table of Contents

FDA PROPOSED DISCLOSURE RULE

An Example of Complexity: Gene Therapy Products

Gene Therapy and Xenotransplantation Products Come From Nature...

Consequences From Biologics

Consequences From Biologics

Proposed Rule on Public Disclosure

SCOPE and PURPORSE

WHAT IS NOT DISCLOSABLE

WHAT IS DISCLOSABLE, 601.52

WHAT IS DISCLOSABLE, 601.52

HOW WILL THIS INFORMATION BE DISCLOSED? 601.53

…lessons from the past enable the future: “What can be imagined, will be done”

Author: Phil Noguchi