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FDA regulatory affairs = a guide for...

United States., Food and Drug Administration

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FDA regulatory affairs = a guide for prescription drugs, medical devices, and biologics /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	FDA regulatory affairs/ edited by Douglas J. Pisano, David S. Mantus.
其他題名:	a guide for prescription drugs, medical devices, and biologics /
其他作者:	Pisano, Douglas J.
出版者:	New York :Informa Healthcare USA, : c2008.,
面頁冊數:	viii, 448 p. :ill.
內容註:	1. Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- 2. What is an IND / Michael R. Hamrell -- 3. The new drug application / Charles Monahan and Josephine C. Babiarz -- 4. Meeting with the FDA / Alberto Grignolo -- 5. FDA medical device regulation / Barry Sall -- 6. The development of orphan drugs / Tan T. Nguyen -- 7. CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- 8. Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- 9. FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- 10. Electronic submissions : a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vah�e Ghahraman -- 11. The practice of regulatory affairs / David S. Mantus -- 12. A primer of drug/device law : what's the law and how do I find it? / Josephine C. Babiarz -- 13. FDA advisory committees / Christina A. McCarthy and David S. Mantus -- 14. Biologics / Timothy A. Keutzer.
標題:	Drug development - United States. -
電子資源:	http://marc.crcnetbase.com/isbn/9781420073553Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:	9781420073553 (ebook : PDF)

FDA regulatory affairs = a guide for prescription drugs, medical devices, and biologics /
FDA regulatory affairsa guide for prescription drugs, medical devices, and biologics /[electronic resource] :edited by Douglas J. Pisano, David S. Mantus. - 2nd ed. - New York :Informa Healthcare USA,c2008. - viii, 448 p. :ill.

Includes bibliographical references and index.

1. Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- 2. What is an IND / Michael R. Hamrell -- 3. The new drug application / Charles Monahan and Josephine C. Babiarz -- 4. Meeting with the FDA / Alberto Grignolo -- 5. FDA medical device regulation / Barry Sall -- 6. The development of orphan drugs / Tan T. Nguyen -- 7. CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- 8. Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- 9. FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- 10. Electronic submissions : a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vah�e Ghahraman -- 11. The practice of regulatory affairs / David S. Mantus -- 12. A primer of drug/device law : what's the law and how do I find it? / Josephine C. Babiarz -- 13. FDA advisory committees / Christina A. McCarthy and David S. Mantus -- 14. Biologics / Timothy A. Keutzer.

Mode of access: World Wide Web.

ISBN: 9781420073553 (ebook : PDF)Subjects--Corporate Names:

2123237
United States.
Food and Drug Administration--Rules and practice.Subjects--Topical Terms:

916415
Drug development
--United States.Index Terms--Genre/Form:

542853
Electronic books.

FDA regulatory affairs = a guide for prescription drugs, medical devices, and biologics /
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300 $a viii, 448 p. : $b ill.
504 $a Includes bibliographical references and index.
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530 $a Also available in print edition.
538 $a Mode of access: World Wide Web.
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