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Berry, Ira R (ed) & Martin, Robert P (ed)

The Pharmaceutical regulatory process .-2nd ed .-9781420070422 - Informa Healthcare, New York 2008 - x,469

Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann -- Modernizing the Food And Drug Administration / Arthur Y. Tsien -- The new drug approval- process - before and after 1962 / Michael P. Peskoe -- Generic drug-approval process - Hatch-Waxman update / Marc S. Gross ... [et al.] -- FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- FDA’s antibiotic regulatory scheme : then and now / Irving L. Wiesen -- Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.] -- The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson -- Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley -- Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- Drugs marketed without FDA approval / Jane Baluss and David Rosen -- FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England.~~2nd ed~~text~~ill.~New York~Informa Healthcare~Hb~9781420070422~Drugs and the pharmaceutical sciences a series of textbooks and monographs~~The Pharmaceutical regulatory process~Rs. 6995~x,469~2008~~~~~~~~~

ISBN: 9781420070422

Dewey Class. No.: 344.7304 Ber/Mar