03325nam a22003497a 450000100060000000300090000600800410001501000170005601600200007302000180009302000430011104000230015408200200017724500870019726000610028430000440034549000490038950400510043850510520048950509930154152600080253465000500254265000470259265000380263965000690267765000590274665000140280570000260281970000370284583000530288285200400293539349BD-DhAAL220814r20222008nyua     b    001 0 eng d  a  20080426617 a1014854572DNLM  a9780367202842  a9781420070422 (hardcover : alk. paper)  aBD-DhAALcBD-DhAAL00a344.730423322304aThe pharmaceutical regulatory process /cedited by Ira R. Berry, Robert P. Martin.  aNew York :bInforma Healthcare,cc2008 [reprinted 2022].  ax, 469 pages :billustrations ;c24 cm.1 aDrugs and the pharmaceutical sciences ;v185  aIncludes bibliographical references and index.0 aPharmaceutical 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.0 aActive 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.  aPHR 0aPharmacyxLaw and legislationzUnited States. 0aDrugsxLaw and legislationzUnited States.12aLegislation, DrugzUnited States.22aGuideline Adherencexlegislation & jurisprudencezUnited States.22aPharmaceutical PreparationsxstandardszUnited States.22aPharmacy.1 aBerry, Ira R.,d1942-1 aMartin, Robert P.q(Robert Paul) 0aDrugs and the pharmaceutical sciences ;vv. 185.  aAyesha Abed LibrarycGeneral Stacks