FDA Guidance Concerning Demonstration of Comparability of Human biological products, including thera

FDA Guidance Concerning Demonstration of Comparability of Human biological products, including thera

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FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER)
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APRIL 1996
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TABLE OF CONTENTS I. INTRODUCTION. ........................................ 1 II. BACKGROUND. .......................................... 1 III. PRODUCT COMPARABILITY TESTING. ....................... 4 A. Analytical Testing. ............................. 5 B. Bioassays. ...................................... 5 C. Preclinical Animal Studies. ..................... 6 D. Clinical Studies. ............................... 6 E. Additional Considerations. ...................... 7 IV. DOCUMENTATION OF PRODUCT COMPARABILITY. .............. 7 V. CONCLUSION. .......................................... 8 VI. REFERENCES. .......................................... 9
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April 1996 FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products I. Introduction FDA is issuing this guidance document as part of its on-going initiatives to provide manufacturers with increased flexibility to bring important and improved human biological products to market more efficiently and expeditiously. This document addresses the concept of product comparability and describes current FDA practice concerning product comparability of human biological products regulated by the Center for Biologics Evaluation and Research (CBER), including therapeutic biotechnology-derived products, regulated by CBER, and therapeutic biotechnology-derived products regulated by the Center for Drug Evaluation and Research (CDER). It describes those steps that manufacturers may perform and which FDA may evaluate to allow manufacturers to make manufacturing changes without performing additional clinical studies to demonstrate safety and efficacy. As with other guidance documents FDA does not intend this document to be all inclusive. It is intended to provide information and does not set forth requirements. Manufacturers may follow the procedures outlined in this document or may choose to use alternative procedures that are not provided in this document. Prior to using alternative procedures a manufacturer may wish to discuss the matter with FDA to prevent expenditure of resources generating data that FDA may later determine to be unacceptable. Although this guidance document does not create or confer any rights for or on any person and does not operate to bind FDA or the public, it does represent the agency's current thinking on demonstration of product
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comparability. Where this document reiterates a requirement imposed by statute or regulation, the force and effect as law of the requirement is not changed in any way by virtue of its inclusion in this document. II.
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FDA Guidance Concerning Demonstration of Comparability of Human biological products, including thera

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