UCM126051 - Guidance for Industry New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products DRAFT

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09/30/08 1 Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by 90-days after publication in the Federal Register. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register . Submit electronic comments to http://www.regulations.gov . For questions regarding this draft document contact Patricia Y. Love, MD in the Office of Combination Products (OCP) at 301-437-1934. U.S. Department of Health and Human Services Food and Drug Administration Office of Combination Products (OCP) in Office of Commissioner Center for Devices and Radiological Health (CDRH) Center for Drug Evaluation and Research (CDER) September 2008
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Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products Additional copies are available from: Office of Combination Products, HFG-3 Office of the Commissioner Food and Drug Administration 15800 Crabbs Branch Way 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 Combination Products (OCP) in Office of the Commissioner Center for Devices and Radiological Health (CDRH) Center for Drug Evaluation and Research (CDER) September 2008 2
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Contains Nonbinding Recommendations Draft — Not for Implementation TABLE OF CONTENTS I. INTRODUCTION. ............................................................................................................ 4 II. PURPOSE. ......................................................................................................................... 5 III. TERMINOLOGY. ............................................................................................................ 5 IV. SCOPE. .............................................................................................................................. 6 V. BACKGROUND. .............................................................................................................. 6 VI. REVIEW PRINCIPLES. .................................................................................................. 9 VII. PREMARKET DEVELOPMENT CONSIDERATIONS. .......................................... 10 A. Determinations of Lead Center Responsible for Premarket Review. ............... 10 B.
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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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UCM126051 - Guidance for Industry New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products DRAFT

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