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020 z| 9781841849195 (hardcover : alk. paper);

020 a| 9781841849201 (e-book);

035 a| (Sirsi) o872703723;

035 a| (MiAaPQ)EBC1407577;

035 a| (Au-PeEL)EBL1407577;

035 a| (CaPaEBR)ebr10827809;

035 a| (CaONFJC)MIL694501;

035 a| (OCoLC)869639807;

043 a| n-us---;

050 4 a| RM301.25b| .F33 2014eb;

082 0 a| 615/.192| 23;

245 00 a| FDA regulatory affairs /c| edited by David Mantus, Douglas J. Pisano.;

250 a| Third edition.;

264 1 a| Boca Raton :b| Taylor & Francis,c| [2014];

300 a| 1 online resource (392 pages);

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

504 a| Includes bibliographical references.;

505 0 a| 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 -- The practice of regulatory affairs / David S. Mantus -- FDA advisory / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner.;

588 a| Description based on print version record.;

610 10 a| United States.b| Food and Drug Administrationv| Rules and practice.;

650 0 a| Drug developmentz| United States.;

650 0 a| Pharmaceutical industryz| United States.;

650 0 a| Biological productsx| Standardsz| United States.;

655 4 a| Electronic books.;

700 1 a| Pisano, Douglas J.;

700 1 a| Mantus, David.;

797 2 a| ProQuest (Firm);

856 40 u| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=1407577z| Click to View;

949 a| Click on web addressw| asish| joyner96o| jjlm;

949 a| Click on web addressw| asish| hsl102o| jjlm;

590 a| Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.;

596 a| 1 4;

998 a| 4709432;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 4709432-1001l| HSLELECm| HSLp| $159.95r| Ys| Yt| HGENEBKu| 6/23/2017x| EBOOKz| HERESOURCE0| HSLo| .STAFF. HMB;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 4709432-2001l| JNETm| JOYNERr| Ys| Yt| JNE3BKu| 6/23/2017x| EBOOKz| JERESOURCEo| .STAFF. HMB;

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

Other author	Pisano, Douglas J.
Other author	Mantus, David.
Format	Electronic
Edition	Third edition.
Publication	Boca Raton : Taylor & Francis, [2014]
Copyright Date	©2014
Description	1 online resource (392 pages)
Supplemental Content	Click to View
Subjects	United States. Food and Drug Administration--Rules and practice. Drug development--United States. Pharmaceutical industry--United States. Biological products--Standards. --United States.

Contents	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 -- The practice of regulatory affairs / David S. Mantus -- FDA advisory / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner.
Local note	Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.
Bibliography note	Includes bibliographical references.
Source of description	Description based on print version record.
Issued in other form	Print version: FDA regulatory affairs. Boca Raton : Taylor & Francis, [2014] xii, 378 pages 9781841849195
Genre/form	Electronic books.
ISBN	9781841849201 (e-book)

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