FDA regulatory affairs / edited by David Mantus, Douglas J. Pisano.
Material type: TextPublication details: Boca Raton, FL : CRC Press, Taylor & Francis Group, [2014]Edition: Third editionDescription: xii, 387 pages ; 24 cmISBN:- 9781841849195
- United States. Food and Drug Administration
- Medicine: general issues
- United States of America, USA
- Regulation of medicines & medical devices
- Pharmaceutical chemistry & technology
- Drug Approval -- 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
Item type | Current library | Call number | Copy number | Status | Date due | Barcode |
---|---|---|---|---|---|---|
Short Loan Collection | Carlow Campus Library Short Loan Collection | 615.19 (Browse shelf(Opens below)) | 1 | Available | 82016 |
Overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- What is an IND? / Michael R. Hamrell -- The new drug application / Charles Monahan and Josephine C. Babiarz -- Meetings with the FDA / Alberto Grignolo and Sally Choe -- FDA medical device regulation / Barry Sall -- A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- The development of orphan drugs / Scott N. Freeman -- CMC sections of regulatory filings and CMC regulatory Compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- Overview of the GxPs for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake, Esq. -- The practice of regulatory affairs / David S. Mantus -- FDA advisory Committees / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner, Esq
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