UCM147095 - Draft Guidance for Industry and FDA Staff:...

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Unformatted text preview: Draft Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products DRAFT GUIDANCE This guidance document is for comment purposes only. Written comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to 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 . Additional copies are available from the Office of Combination Product, 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; or http://www.fda.gov/oc/combination . For questions regarding this document, contact Patricia Y. Love, MD, Office of Combination Products, at 301-427-1934 or patricia.love@fda.hhs.gov . U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, Center for Drug Evaluation Research, Center for Biologics Evaluation and Research, and Office of Combination Products in the Office of the Commissioner. April 2009 Contains Nonbinding Recommendations Draft - Not for Implementation 2 Draft Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products Additional copies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, 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 Center for Devices and Radiological Health, Center for Drug Evaluation Research, Center for Biologics Evaluation and Research, and Office of Combination Products in the Office of the Commissioner. April 2009 Contains Nonbinding Recommendations Draft - Not for Implementation 3 Table of Contents INTRODUCTION.....................................................................................................................4 The Least Burdensome Approach ..................................................................................... 5 BACKGROUND .......................................................................................................................5 SECTION I: SCIENTIFIC AND TECHNICAL CONSIDERATIONS..............................6 A. Injector Description......................................................................................................6 B. Design Features...........................................................................................................10 C. Injector Materials of Construction and Manufacture.............................................14 C....
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UCM147095 - Draft Guidance for Industry and FDA Staff:...

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