Development and approval of combination products : a regulatory perspective / edited by Evan B. Siegel.

• Material Type: 図書
• ISBN: 9780470050941 (hbk.)
• Title: Development and approval of combination products : a regulatory perspective / edited by Evan B. Siegel.
• Author Heading: Siegel, Evan B.
• Publication, Distribution, etc.: Hoboken, N.J. : Wiley
• Publication Date: c2008.
• Publication Date (W3CDTF): 2008
• Extent: xii, 215 p. : ill. ; 25 cm.
• Place of Publication (Country Code): US
• Text Language Code: eng
• Subject Heading: United States. Food and Drug Administration.; Drug approval -- United States.; Biological products -- United States.; Medical instruments and apparatus -- United States.; Drug Approval -- legislation & jurisprudence -- United States.; Drug Combinations -- United States.; Device Approval -- legislation & jurisprudence -- United States.
• LCC: RA401.5
• DDC: 363.19/46
• NDLC: SD81
• Note (General): Related URL: Publisher description http: //www.loc.gov/catdir/enhancements/fy0808/2008001360-d.html.; Related URL: Table of contents only http: //www.loc.gov/catdir/enhancements/fy0808/2008001360-t.html.; Related URL: Contributor biographical information http: //www.loc.gov/catdir/enhancements/fy0833/2008001360-b.html.
• Note (Bibliography): Includes bibliographical references and index.
• Holding library: 国立国会図書館
• Call No.: SD81-B20
• Data Provider (Database): 国立国会図書館 : 国立国会図書館蔵書; https://ndlsearch.ndl.go.jp
• Bibliographic ID (NDL): 000010564399; http://id.ndl.go.jp/bib/000010564399
• LC Control Number: 2008001360; https://lccn.loc.gov/2008001360
• OCLC No.: 190867380; https://www.worldcat.org/oclc/190867380
• Cataloging Rule: Anglo-American Cataloging Rules
• Bibliographic Record Category (NDL): 211

• Contents: Overview of combination products development and regulatory review / Evan B. SiegelDetailed regulatory approaches to development, review, and approval...