The pharmaceutical regulatory process
"Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States - standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality issues influencing the pharmaceutical industry."--BOOK JACKET
xiii, 711 pages : illustrations ; 25 cm.
9780824754648, 0824754646
57434176
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 [and others]
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 [and others]
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