ucm126054 - Contains Nonbinding Recommendations Guidance...

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Contains Nonbinding Recommendations Guidance for Industry and FDA Staff: Early Development Considerations for Innovative Combination Products For questions regarding this document, contact: Patricia Y. Love, MD, Office of Combination Products, at 301-427-1934. U.S. Department of Health and Human Services Food and Drug Administration Office of the Commissioner Office of Combination Products September 2006
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Contains Nonbinding Recommendations Guidance for Industry and FDA Staff Early Development Considerations for Innovative Combination Products Additional copies are available from: Office of Combination Products, HFG-3 Office of the Commissioner Food and Drug Administration 15800 Crabbs Branch Way, Suite 200 Rockville, MD 20855 (Tel) 301-427-1934 (Fax) 301-427-1935 http://www.fda.gov/oc/combination U.S. Department of Health and Human Services Food and Drug Administration Office of the Commissioner Office of Combination Products (OCP) September 2006
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Contains Nonbinding Recommendations Public Comment Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments . When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
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Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION. ............................................................................................................ 1 II. BACKGROUND. .............................................................................................................. 2 A. Definition . .......................................................................................................................... 3 B. How are combination products regulated? . ................................................................... 3 III. GENERAL DEVELOPMENT CONSIDERATIONS. .................................................. 5 IV. CURRENTLY MARKETED PRODUCT CONSIDERATIONS . ............................... 6 V. PERSPECTIVES BY CONSTITUENT PART. ............................................................. 7 A. Device constituent considerations. ................................................................................... 7 B. Drug and biological product constituent considerations. .............................................. 8 VI. ADDITIONAL PERSPECTIVES . ................................................................................ 10 A. Clinical Investigation. ..................................................................................................... 10 B. Manufacturing considerations. ...................................................................................... 11 C. Reliance on information not developed by the applicant. ...........................................
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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ucm126054 - Contains Nonbinding Recommendations Guidance...

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