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FDA regulatory affairs / edited by Douglas J. Pisano, David Mantus.

Contributor(s): Pisano, Douglas J [editor.] | Mantus, David [editor.].
Material type: TextTextSeries: Medicine Net Base eBooks.Publisher: Boca Raton : CRC Press, [2014]Copyright date: �2014Edition: Third edition.Description: 1 online resource : text file, PDF.Content type: text Media type: computer Carrier type: online resourceISBN: 9781841849201 (ebook : PDF).Subject(s): Drug development -- United States | Drugs -- Research -- United States | United States. Food and Drug AdministrationAdditional physical formats: Print version:: No titleOnline resources: Click here to view this ebook. Also available in print format.
Contents:
chapter 1. Overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- chapter 2. What is an IND? / Michael R. Hamrell -- chapter 3. The new drug application / Charles Monahan and Josephine C. Babiarz -- chapter 4. Meetings with the FDA / Alberto Grignolo and Sally Choe -- chapter 5. FDA medical device regulation / Barry Sall -- chapter 6. A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- chapter 7. The development of orphan drugs / Scott N. Freeman -- chapter 8. CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- chapter 9. Overview of the GxPs for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- chapter 10. FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- chapter 11. The practice of regulatory affairs / David S. Mantus -- chapter 12. FDA advisory committees / Christina A. McCarthy and David S. Mantus -- chapter 13. Biologics / Florence Kaltovich -- chapter 14. Regulation of combination products in the United States / John Barlow Weiner.
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Item type Current location Call number URL Status Date due Barcode
Electronic Book UT Tyler Online
Online
RM301.25 F337 2014 (Browse shelf) https://ezproxy.uttyler.edu/login?url=http://marc.crcnetbase.com/isbn/9781841849201 Available CRC0HE10486PDF

Includes bibliographical references and index.

chapter 1. Overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- chapter 2. What is an IND? / Michael R. Hamrell -- chapter 3. The new drug application / Charles Monahan and Josephine C. Babiarz -- chapter 4. Meetings with the FDA / Alberto Grignolo and Sally Choe -- chapter 5. FDA medical device regulation / Barry Sall -- chapter 6. A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- chapter 7. The development of orphan drugs / Scott N. Freeman -- chapter 8. CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- chapter 9. Overview of the GxPs for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- chapter 10. FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- chapter 11. The practice of regulatory affairs / David S. Mantus -- chapter 12. FDA advisory committees / Christina A. McCarthy and David S. Mantus -- chapter 13. Biologics / Florence Kaltovich -- chapter 14. Regulation of combination products in the United States / John Barlow Weiner.

Also available in print format.

Author notes provided by Syndetics

<p>David Mantus worked in the biotechnology and pharmaceutical industry for more than 20 years. He not only served as vice president of regulatory affairs at Cubist Pharmaceuticals but also held various regulatory roles at Sention Inc., Shire Biologics, PAREXEL, the Massachusetts Public Health Laboratory, the Massachusetts College of Pharmacy and Health Sciences, and Procter and Gamble Pharmaceuticals. He received his BS in chemistry from the College of William and Mary, his MS and Ph.D in chemistry from Cornell University, and was a post-doctoral research fellow in biomedical engineering at the University of Washington. He is currently associate professor of pharmaceutical sciences and director, regulatory affairs at MCPHS University in Boston.</p> <p> Douglas J. Pisano received his Ph.D in law, policy, and society from Northeastern University. He has participated on the editorial advisory boards of multiple journals and received the Special Service Award for the Enhancement of Regulatory Education from the Regulatory Affairs Professionals Society. A registered pharmacist and active member of several professional organizations, including the American Association of Colleges of Pharmacy and the Regulatory Affairs Professionals Society, he formerly served as dean of the School of Pharmacy-Boston and is currently professor of pharmacy administration, vice-president of academic affairs, and provost at MCPHS University in Boston.</p>

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