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Document Type: Book
All Authors / Contributors: David G Adams, J.D.; Richard M Cooper; Martin J Hahn; Jonathan S Kahan; Food and Drug Law Institute (U.S.),
ISBN: 9781935065739 1935065734
OCLC Number: 908204515
Description: xviii, 995 pages ; 27 cm
Contents: Introduction / Richard M. Cooper --
Food safety / Fred H. Degnan, Christina M. Markus, and Smitha G. Stansbury --
Food labeling / Mel Drozen and Eve Pelonis --
Food and drug packaging / Devon Wm. Hill and Deborah C. Attwood --
Food : meat and poultry inspection / Brett T. Schwemer and Jolyda O. Swaim --
Dietary supplements / William R. Pendergast, Brian P. Waldman and Marsha C. Wertzberger --
Veterinary food and drugs / Jeannie Perron --
Cosmetic regulation revisited / Gary L. Yingling, Morgan Lewis and Suzan Onel --
Drugs : general requirements / Daniel Kracov and Abeba Habtemariam --
Drugs : INDs and full NDAs / James N. Czaban and Geoffrey M. Levitt --
Generic drugs : ANDAs, section 505(b)(2) applications, patents and exclusivities / Frederick R. Ball and Carolyn A. Alenci --
Prescription drug promotion and marketing / Kathleen M. Sanzo and Stephen Paul Mahinka --
Over-the-counter drugs / Stacy L. Ehrlich and Daniel R. Dwyer --
Human biologics / Edward L. Korwek and Michael N. Druckman --
Biosimilars / Erika Lietzan and Laura Sim --
Medical devices / Jonathan S. Kahan, Edward C. Wilson, Jr. and Michael S. Heyl --
Combination products and jurisdictional issues / Jeffrey K. Shapiro --
Tobacco products / Joseph A. Page --
FDA regulation of healthcare professionals / David G. Adams --
FDA administrative procedures / Ann H. Wion --
FDA enforcement powers / Scott Bass and William McConagha --
Medical countermeasures : emergency preparedness and response roles and authorities / Brooke Courtney and Elizabeth Sadov --
Food and Drug regulation in the EU / Elizabethann Wright, Fabien Roy and Ciara Farrell --
FTC regulation of advertising / Anne V. Maher and Lesley Fair --
DEA regulation of controlled substances and listed chemicals / John A. Gilbert, Jr. and Karla L. Palmer --
Reimbursement, fraud and abuse / Gail L. Daubert, Joseph W. Metro and Gordon B. Schatz.
Responsibility: edited by David G. Adams (Partner, Venable LLP, Adjunct Professor, George Washington University Law School), Richard M. Cooper (Partner, Williams & Connolly LLP), Martin J. Hahn (Partner, Hogan Lovells LLP), Jonathan S. Kahan (Partner, Hogan Lovells LLP, George Washington University Law School).

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