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14 Biotechnology L. Rep. [i] (1995)

handle is hein.journals/bothnl14 and id is 1 raw text is: Biotechnology Law Report Editor in Chief GERRY J. ELMAN Ebnan Wilj & Fried Media, PA Senior Editors STEPHEN BENT' Foley & Lardner Washington, DC ARTHUR SIRKIN Golden Valley Consulting Golden Valley. MN Managing Editor JUDrH GUNN BRONSON New Brighton, MN Editorial Board GEORGE J. ANNAS Boston Univerity~ PHILIP L. BEREANO University of Washington IVER P. COOPER Browdy and Neimark, Washington, D.C. BRUCE M. EISEN Cambridge. MA WILUAM S. FEILER Morgan & Finnegan Noew York CARL FELDBAUM BID ALBERT P. HALLUIN Pennie & Edmtonds Menlo Pork, CA MICHAEL J. HOULIHAN Callina Lecie Victoria, Australia PETER BARTON HUrr Covintgton & Barling Washington' D.C. HANS-RAINER JAENICHEN Vossians & Paner lansich. Germany GEOFFREY M. KARNY Genetic Therapy, Inc. EDWARD L KORWEK Hogan & Hartson Watshingon. D.C. BRUCE P. MACKLER Fenwick & West Washington. D.C. RANDALL W. MARUSYK Manayk Bourassa Milton Ottawa. Ontario. Canada MARTIN L MCGREGOR Baker & Boas Houston ROBERT B. NICHOLAS McDer-oa. Will & Etery Waohiagton. D.C. JOSEPH G. PERPICH Howard Hughes Medical Institute HONORABLE GILES S. RICH U.S. Court of Appeals, Federal Circuit EDWARD LEE ROGERS Washington. D.C. BERTRAM I. ROWLAND Flehr. Hotbach, Test San Francis00 DANYL STOTLAND IA.F. BioChem Intl. Montreal Quebec Canada HAROLD C. WEGNER George Washington University VOLUME 14 NUMBER 1 JANUARY-FEBRUARY 1995 TABLE OF CONTENTS COMMENT FDA's Legally Suspect Actions Invite Challenge. By Glenn G. Lammi {B L R 1920} .............................................................................1 Taking Biotechnology International: Practical Business and Legal Considerations of Global Alliances. By Peter C. Linzmeyer {BLR 1921}.....6 LEGISLATIVE AND EXECUTIVE ACTIONS Is the Fourth Time the Charm? Biotechnology Process Patent Bill Introduced {BLR 1922}..............................................................13 <<< TEXT of H.R. 587 {BLR 1923} ..............................................14 REGULATORY AFFAIRS - PHARMACEUTICAL Innovative Approaches to the Building of High-Quality Biopharmaceutical Facilities. By Bruce R. Moon {BLR 1924}.......................................17 FDA Picks Place for New Digs {BLR 1925}..........................................19 More Information, Please ... FDA Asks CellPro for Data {BLR 1936}............21 HemaSure Files for Clearance of Filter that Removes Leukocytes from B lood {B L R 1937}....................................................................2 1 A Better Way to Detect Bladder Cancer? {BLR 1938} ........................... 22 Immunomedics Gets Nod on Manufacturing Facility {BLR 1939}..................23 Russia Plans Strict Controls on Genetic Engineering {BLR 1940}..................23 CLINICAL TRIALS Gensia Responds to Slavin and Arkebauer Comment Appearing in September-October 1994 Issue {BLR 1941}......................................24 (CONTENTS CONTINUED INSIDE FRONT COVER) t1y A*fes L4L4, Io