04756nam a22004577a 4500 39349 BD-DhAAL 220814r20222008nyua b 001 0 eng d 44798 44798 2008042661 101485457 DNLM 9780367202842 9781420070422 (hardcover : alk. paper) BD-DhAAL BD-DhAAL 344.7304233 23 The pharmaceutical regulatory process / edited by Ira R. Berry, Robert P. Martin. New York : Informa Healthcare, c2008 [reprinted 2022]. x, 469 pages : illustrations ; 24 cm. Drugs and the pharmaceutical sciences ; 185 Includes bibliographical references and index. 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. PHR Paragon Enterprises LTD 39349, 39350, 39351, 39352, 39353, 39354 Pharmacy Law and legislation United States. 50825 Drugs Law and legislation United States. 50826 Legislation, Drug United States. 50827 Guideline Adherence legislation & jurisprudence United States. 50828 Pharmaceutical Preparations standards United States. 50829 Pharmacy. 50830 Berry, Ira R., 1942- 50831 Martin, Robert P. (Robert Paul) 50832 Drugs and the pharmaceutical sciences ; v. 185. 50833 Ayesha Abed Library General Stacks ddc BK 0 0 ddc 0 344_730423300000000_PHA 0 71623 BRACUL BRACUL GEN 2022-08-08 Paragon Enterprises LTD 3770.00 0 344.7304233 PHA 3010039351 2022-08-08 3 3770.00 2022-08-08 BK 0 0 ddc 0 344_730423300000000_PHA 0 71624 BRACUL BRACUL GEN 2022-08-08 Paragon Enterprises LTD 3770.00 0 344.7304233 PHA 3010039354 2022-08-08 6 3770.00 2022-08-08 BK 0 0 ddc 0 344_730423300000000_PHA 0 71625 BRACUL BRACUL GEN 2022-08-08 Paragon Enterprises LTD 3770.00 0 344.7304233 PHA 3010039350 2022-08-08 2 3770.00 2022-08-08 BK 0 0 ddc 0 344_730423300000000_PHA 0 71626 BRACUL BRACUL GEN 2022-08-08 Paragon Enterprises LTD 3770.00 1 1 344.7304233 PHA 3010039352 2023-10-02 2023-09-13 4 3770.00 2022-08-08 BK 0 0 ddc 0 344_730423300000000_PHA 0 71627 BRACUL BRACUL GEN 2022-08-08 Paragon Enterprises LTD 3770.00 0 344.7304233 PHA 3010039349 2022-08-08 1 3770.00 2022-08-08 BK 0 0 ddc 0 344_730423300000000_PHA 0 71628 BRACUL BRACUL GEN 2022-08-08 Paragon Enterprises LTD 3770.00 0 344.7304233 PHA 3010039353 2022-08-08 5 3770.00 2022-08-08 BK