Matches in Library of Congress for { <http://lccn.loc.gov/2013047346> ?p ?o. }
Showing items 1 to 21 of
21
with 100 items per page.
- 2013047346 contributor B12755099.
- 2013047346 date "2014".
- 2013047346 description "Includes bibliographical references and index.".
- 2013047346 description "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.".
- 2013047346 extent "p. ;".
- 2013047346 identifier "9781841849195 (hardcover : alk. paper)".
- 2013047346 issued "2014".
- 2013047346 language "eng".
- 2013047346 spatial "United States.".
- 2013047346 subject "615/.19 23".
- 2013047346 subject "Biological Products standards United States.".
- 2013047346 subject "Drug Approval United States.".
- 2013047346 subject "Equipment and Supplies standards United States.".
- 2013047346 subject "Government Regulation United States.".
- 2013047346 subject "QV 771".
- 2013047346 subject "RM301.25".
- 2013047346 subject "United States Government Agencies United States.".
- 2013047346 subject "United States. Food and Drug Administration.".
- 2013047346 tableOfContents "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.".
- 2013047346 title "FDA regulatory affairs / editors, Douglas J. Pisano, David Mantus.".
- 2013047346 type "text".