FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics/ Ed by Douglas J. Pisano, David S. Mantus.
Publication details: New York: Informa Healthcare USA, 2008.Edition: 2nd edDescription: viii, 448 p. illISBN:- 9781420073546
- 615.19 P81
Item type | Current library | Call number | Status | Date due | Barcode | Item holds |
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Books | Mahatma Gandhi University Library General Stacks | 615.19 P81 (Browse shelf(Opens below)) | Available | 49840 |
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615.19 P31 Bio-pharmaceuticals: | 615.19 P73 Medicinal chemistry: | 615.19 P74 Pharmaceutical biotechnology: | 615.19 P81 FDA regulatory affairs: | 615.19 P91 Drugs: | 615.19 Q01 Drug design : | 615.19 Q11 Wilson and Gisvold's text book of organic medicinal and pharmaceutical chemistry/ |
Includes bibliographical references and index.
Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahé Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer.
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