FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics / edited by Douglas J. Pisano, David S. Mantus.
Material type: TextPublication details: New York : Informa Healthcare USA, c2008.Edition: 2nd edDescription: viii, 448 p. : ill. ; 24 cmISBN:- 9781420073546 (hbk. : alk. paper)
- 9781420073546 (Cloth)
- United States. Food and Drug Administration -- Rules and practice
- United States. Food and Drug Administration
- Goverment regulation -- United States
- Equipment and supplies -- Standards -- United States
- Biological products -- Standards -- United States
- United States goverment agencies -- United States
- Drug development -- United States
- Pharmaceutical industry -- United States
- Clinical trials
- Pharmaceutical chemistry & technology
- Drug Industry -- standards -- United States
- United States Government Agencies -- United States
- Biological Products -- standards -- United States
- Equipment and Supplies -- standards -- United States
- Government Regulation -- United States
- 615.19 PIS
- RM301.25 .F37 2008
Item type | Current library | Call number | Copy number | Status | Date due | Barcode | |
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Short Loan | TUS: Midlands, Main Library Athlone General Lending | 615.19 PIS (Browse shelf(Opens below)) | 1 | Available | 00214449 | ||
Short Loan | TUS: Midlands, Main Library Athlone General Lending | 615.19 PIS (Browse shelf(Opens below)) | 1 | Available | 00214448 |
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.