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How to work with the FDA : tips from the experts

Author: Wayne L Pines
Publisher: Washington, DC : FDLI, ©2003.
Edition/Format:   Print book : English : 2nd edView all editions and formats
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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Wayne L Pines
ISBN: 1885259786 9781885259783
OCLC Number: 52314638
Notes: Includes index.
Description: iii, 250 pages : portrait ; 26 cm
Contents: How to get your drug product approved / Kathleen M. Sanzo --
How to get your biologic product approved / Bogdan Dziurzynski --
How to get your animal drug product approved / Eugene I. Lambert & Jeannie M. Perron --
How to get your medical device approved / Dvorah A. Richman --
How to get your food additive product approved / Martin J. Hahn & Richard S. Silverman --
How to get your dietary supplement product "approved" / Daniel A. Kracov & Jennifer J. Spokes --
Obtaining information from FDA / Andrea E. Chamblee --
How to work with an FDA advisory committee / Wayne L. Pines --
How to appeal an adverse product approval decision / Kate C. Beardsley --
Persuading FDA to your position / Mark E. DuVal --
Petitioning the FDA / Richard O. Wood --
How to write letters to FDA / William W. Vodra --
How to deal with a recall / Mark Vare & Michael R. McConnell --
How to deal with warning letters / Arthur N. Levine --
Seizures, injunctions, and consent decrees / Douglas B. Farquhar --
Criminal investigations / Steven M. Kowal --
How to prepare for an FDA inspection / Anthony C. Celeste --
How to handle an FDA inspection / Ronald M. Johnson --
After the inspection: addressing the 483 and the establishment inspection report / Alan H. Kaplan & Stacy L. Ehrlich --
Communicating with FDA's advertising groups / Minnie V. Baylor-henry & Janet L. "Lucy" Rose --
Reporting stolen or lost drug samples / Douglas B. Farquhar --
Combination products / David L. West --
Working with an association to achieve goals at FDA / Marjorie E. Powell --
Some tips on FDA etiquette I / Peter H. Rheinstein --
Tips on FDA etiquette: field offices vs. headquarters / Ronald M. Johnson --
Some tips on FDA etiquette II / Joseph Paul Hile --
Some tips on FDA etiquette III / Andrea E. Chamblee --
From FDA's perspective / James C. Morrison.
Responsibility: Wayne L. Pines, editor.
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