The pharmaceutical regulatory process
By: edited by Ira R. Berry, Robert P. Martin.
Contributors: Berry, Ira R., 1942-; Martin, Robert P.
Edition: 2nd ed.
Series: Drugs and the pharmaceutical sciences -- v. 185
Publisher: Informa Healthcare USA
Published: 2008
Place of publication: New York
Language: eng
ISBN-13: 9781420070422
Subjects: Pharmacy -- Law and legislation -- United States; Drugs -- Law and legislation -- United States; Legislation, Drug -- United States; Guideline Adherence -- legislation & jurisprudence -- United States; Pharmaceutical Preparations -- standards -- United States
Notes: Includes bibliographical references and index.
Table of contents: title: Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann; title: Modernizing the Food And Drug Administration / Arthur Y. Tsien; title: New drug approval process : before and after 1962 / Michael P. Peskoe; title: Generic drug approval process : Hatch-Waxman Update / Marc S. Gross ... [et al.]; title: FDA regulatory process of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd; title: FDA'santibiotic regulatory scheme : then and now / Irving L. Wiesen; title: Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.]; title: The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson; title: Clinical research requirements for new drug applications / Gary L. Yingling; title: Post-approval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin; title: Drugs marketed without FDA approval / Jane Baluss and David Rosen; title: Legal issues surrounding the importation of foreign APIs / England; title: Active pharmaceutical ingredients / Max S. Lazar; title: Obtaining approval of NDAs and ANDAs from a chemistry, manufacturing, and controls perspective / Shah; title: Obtaining approval of a generic drug : pre- 1984 to present / Loren Gelber; title: New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead; title: Current good manufacturing process and the drug approval process / Ira R. Berry; title: The influence of the USP on the drug approval process / Edward M. Cohen; title: Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo; title: Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta; title: CMC post-approval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour; title: Living with 21 CFR part 11 compliance / Richard L. Burcham.