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.