| Description |
x, 469 pages : illustrations ; 24 cm |
| Series |
Drugs and the pharmaceutical sciences ; v. 185 |
|
Drugs and the pharmaceutical sciences ; 185 |
|
Drugs and the pharmaceutical sciences ; v. 185
|
| Contents |
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 |
|
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, pre-1984 to the present / Loren Gelber -- New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead -- Current good manufacturing practice and the drug approval process / Ira R. Berry -- The influence of the USP on the drug approval process / Edward M. Cohen -- Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo -- Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta -- CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- Living with 21 CFR part 11 compliance / Richard L. Burcham |
| Bibliography |
Includes bibliographical references and index |
| Subject |
Pharmacy -- Law and legislation -- United States.
|
|
Drugs -- Law and legislation -- United States.
|
|
Legislation, Drug.
|
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Guideline Adherence -- legislation & jurisprudence.
|
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Pharmaceutical Preparations -- standards.
|
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United States. |
| Author |
Berry, Ira R., 1942-
|
|
Martin, Robert P. (Robert Paul)
|
| LC no. |
2008042661 |
| ISBN |
9781420070422 hardback |
|
1420070428 hardback |
|
