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Pharmaceutical Manufacturing Handbook: Production and

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56 REGULATORY CONSIDERATIONS IN APPROVAL<br />

REFERENCES<br />

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0355, Mar. 15, 2005 .<br />

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A Regulatory Overview , 3rd ed., Paraxel Intl. , Waltham, MA , pp. 1 – 16 .<br />

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of Therapeutic Products to the Center for Drug Evaluation <strong>and</strong> Research , available:<br />

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14. U.S. Department of Health <strong>and</strong> Human Services (DHHS) ( 1999 , Oct.), Food <strong>and</strong> Drug<br />

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16. Letter of J. Woodcock. (CDER, FDA) to Docket Nos. 2001P - 0323/CP1, 2002P - 0447/CP1,<br />

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18. Letter from S. Galson (CDER, FDA) in response to Docket Nos. 2004P - 023 11CP1 <strong>and</strong><br />

SUP 1,2003P - 0 1 76lCP 1 <strong>and</strong> EMC 1, 2004P - 0171lCP1 <strong>and</strong> 2004N - 0355 (May 30, 2006 ).<br />

19. U.S. Department of Health <strong>and</strong> Human Services, Food <strong>and</strong> Drug Administration, Center<br />

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20. Schellekens , H. ( 2004 ), How similar do “ biosimilars ” need to be ? Nat. Biotechnol . 22 ( 11 ),<br />

1357 – 1359 .

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