The pharmaceutical regulatory process / edited by Ira R. Berry. - New York ; Dhaka : Marcel Dekker ; Bangladesh Photostat, 2005. - xiii, 711 p. : ill. ; 25 cm.

Includes bibliographical references and index.

Pharmaceutical regulation before and after the food, drug, and cosmetic act / John P. Swann --
The new drug-approval process-before and after 1962 / Michael P. Peskoe --
FDA regulation of biological products / James N. Czaban and Natasha Leskovsek --
Generic drug approval process: pre-1984 history concerning generic drugs / David L. Rosen --
Generic drug approval process, post-1984: Hatch-Waxman reform / Marc S. Gross ...[et al.] --
Food and drug administration modernization act / Arthur Y. Tsien and Patricia E. Pahl --
FDA Antibiotic regulatory scheme: then and now / Irving L. Wiesen --
Pioneer and generic drugs: balance between product life cycle extension and anticompetitive behavior / Robert G. Pinco and Barbara A. Binzak --
The influence of the prescription drug user fee act on the approval process / Marc J. Scheineson --
Clinical research requirements for new drug applications / Gary Yingling and Ann Begly --
Active pharmaceutical ingredients / Max S. Lazar --
Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah --
Obtaining approval of a generic drug / Loren Gelber --
Current good manufacturing practice and the drug approval process / Nicholas Buhay --
CMC post-approval regulatory affairs: constantly managing change / Leo J. Lucisano and Kevin A. Miller --
The influence of the USP on the drug approval process / Edward M. Cohen --
Ways and means to U.S. registration of foreign drugs / Alberto Grignolo ...[et al.] --
Common techinical document-quality (M4-Q): one regulatory participant's perspective / Ubrani V. Venkataram --
21 CFR part 11 compliance and beyond / Richard L. Burcham --
Marketing and advertising/promotion: the impact of government regulations / Daniel Glassman, Philip W. McGinn, Jr., and Gene Goldberg --
Approval and marketing of nonprescription or OTC human drugs / William J. Mead. Table of contents

Summary:
A tool to navigate and understand the pharmaceutical regulatory framework. Covering the procedures utilized by pharmaceutical companies for regulatory compliance, this book describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States.



0824754646 (alk. paper) 9780824754648

2005041971


Pharmacy--Law and legislation--United States.
Drugs--Law and legislation--United States.

KF2036.D7 / P47 2005

615.173 / PHA 2005

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