1. Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann -- 2. Modernizing the Food And Drug Administration / Arthur Y. Tsien -- 3. The new drug-approval process : before and after 1962 / Michael P. Peskoe -- 4. Generic drug-approval process : Hatch-Waxman update / Marc S. Gross ... [et al.] -- 5. FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- 6. FDA's antibiotic regulatory scheme : then and now / Irving L. Wiesen -- 7. Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.] -- 8. The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson -- 9. Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley -- 10. Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- 11. Drugs marketed without FDA approval / Jane Baluss and David Rosen -- 12. FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England --

13. Active pharmaceutical ingredients / Max S. Lazar -- 14. Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah -- 15. Obtaining approval of a generic drug, pre-1984 to the present / Loren Gelber -- 16. New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead -- 17. Current good manufacturing practice and the drug approval process / Ira R. Berry -- 18. The influence of the USP on the drug approval process / Edward M. Cohen -- 19. Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo -- 20. Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta -- 21. CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- 22. Living with 21 CFR part 11 compliance / Richard L. Burcham.