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- 2012471405 alternative "Fundamentals of United States regulatory affairs".
- 2012471405 contributor B12635075.
- 2012471405 created "c2011.".
- 2012471405 date "2011".
- 2012471405 date "c2011.".
- 2012471405 dateCopyrighted "c2011.".
- 2012471405 description "History of FDA and related regulatory agencies / by Richard Morroney and Nandini Murthy -- History of food, drug, and cosmetic laws / by Nandini Murthy and Richard Morroney -- Overview of drug, biologic, and device regulatory pathways / by Scott A. Oglesby -- FDA communications and meetings / by Cindy DiBiasi and Kell Cannon -- Preparing for key FDA meetings and advisory committee meetings / by Cindy DiBiasi -- Good laboratory practice regulations / updated by Kurt Stahl and Dana Dunn -- Clinical trials : GCPs, regulations, and compliance / updated by Grant S. Griffin -- Current good manufacturing practice and quality system design / by Christopher Ernst -- Prescription drug submissions / by Naseem Kabir -- Postapproval prescription drug submissions and compliance / by William C. Putnam and Miguel A. de Soto-Perera -- Generic drug submissions / by Kurt R. Karst -- Patents and exclusivity / by Kurt R. Karst -- Over-the-counter drug products / updated by Alice J. Welenc-Masters and David J. Schifkovitz -- Prescription drug labeling, advertising, and promotion / by John Driscoll and Linda Pollitz -- Medical device submissions / by Chas Burr and John DeLucia -- Medical device compliance and postmarketing activities / by Richard Angelo -- Advertising, promotion, and labeling for medical devices and IVDs / updated by Kelly Rowland -- In vitro diagnostics submissions and compliance / by Michael Wienholt -- Biologics submissions / by Marcia Gaido -- Biologics compliance / by Marcia Gaido -- Biologics labeling, advertising, and promotion / updated by Moulakshi Roychowdhury -- Combination products / by Mark D. Kramer -- Regulation of products for small patient populations / updated by Hari Nagaradona -- Blood and blood products / by Sue Sutton-Jones -- Human cell and tissue products / by Martha Wells -- Regulations pertaining to pediatrics / by Susan Hamann -- Dietary supplements and homeopathic products / by Maruthi Prasad Palthur and Evelyn Cadman -- Cosmetics / by Evelyn Cadman -- Veterinary products / updated by Jeff Zinza -- Food products / updated by Evelyn Cadman -- FDA inspection and enforcement / by Alan Minsk and William H. Kitchens -- Healthcare fraud and abuse compliance / updated by Jennifer D. Burgar -- Regulatory information resources in review / by Diane R. Whitworth -- Comparative matrix of regulations across product lines -- Glossary of terms.".
- 2012471405 description "Includes bibliographical references and index.".
- 2012471405 extent "viii, 460 p :".
- 2012471405 identifier "098293212X".
- 2012471405 identifier "9780982932124".
- 2012471405 issued "2011".
- 2012471405 issued "c2011.".
- 2012471405 language "eng".
- 2012471405 publisher "Rockville, MD : RAPS, Regulatory Affairs Professionals Society,".
- 2012471405 spatial "United States.".
- 2012471405 subject "Biological Products standards United States.".
- 2012471405 subject "Biologicals Law and legislation United States.".
- 2012471405 subject "Drugs Law and legislation United States.".
- 2012471405 subject "Equipment and Supplies standards United States.".
- 2012471405 subject "Government Regulation United States.".
- 2012471405 subject "KF1879 .F86 2011".
- 2012471405 subject "Medical instruments and apparatus industry Law and legislation United States.".
- 2012471405 subject "Pharmaceutical Preparations standards United States.".
- 2012471405 tableOfContents "History of FDA and related regulatory agencies / by Richard Morroney and Nandini Murthy -- History of food, drug, and cosmetic laws / by Nandini Murthy and Richard Morroney -- Overview of drug, biologic, and device regulatory pathways / by Scott A. Oglesby -- FDA communications and meetings / by Cindy DiBiasi and Kell Cannon -- Preparing for key FDA meetings and advisory committee meetings / by Cindy DiBiasi -- Good laboratory practice regulations / updated by Kurt Stahl and Dana Dunn -- Clinical trials : GCPs, regulations, and compliance / updated by Grant S. Griffin -- Current good manufacturing practice and quality system design / by Christopher Ernst -- Prescription drug submissions / by Naseem Kabir -- Postapproval prescription drug submissions and compliance / by William C. Putnam and Miguel A. de Soto-Perera -- Generic drug submissions / by Kurt R. Karst -- Patents and exclusivity / by Kurt R. Karst -- Over-the-counter drug products / updated by Alice J. Welenc-Masters and David J. Schifkovitz -- Prescription drug labeling, advertising, and promotion / by John Driscoll and Linda Pollitz -- Medical device submissions / by Chas Burr and John DeLucia -- Medical device compliance and postmarketing activities / by Richard Angelo -- Advertising, promotion, and labeling for medical devices and IVDs / updated by Kelly Rowland -- In vitro diagnostics submissions and compliance / by Michael Wienholt -- Biologics submissions / by Marcia Gaido -- Biologics compliance / by Marcia Gaido -- Biologics labeling, advertising, and promotion / updated by Moulakshi Roychowdhury -- Combination products / by Mark D. Kramer -- Regulation of products for small patient populations / updated by Hari Nagaradona -- Blood and blood products / by Sue Sutton-Jones -- Human cell and tissue products / by Martha Wells -- Regulations pertaining to pediatrics / by Susan Hamann -- Dietary supplements and homeopathic products / by Maruthi Prasad Palthur and Evelyn Cadman -- Cosmetics / by Evelyn Cadman -- Veterinary products / updated by Jeff Zinza -- Food products / updated by Evelyn Cadman -- FDA inspection and enforcement / by Alan Minsk and William H. Kitchens -- Healthcare fraud and abuse compliance / updated by Jennifer D. Burgar -- Regulatory information resources in review / by Diane R. Whitworth -- Comparative matrix of regulations across product lines -- Glossary of terms.".
- 2012471405 title "Fundamentals of US regulatory affairs / RAPS, Regulatory Affairs Professionals Society.".
- 2012471405 title "Fundamentals of United States regulatory affairs".
- 2012471405 type "text".