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64 Food & Drug L.J. [i] (2009)

handle is hein.journals/foodlj64 and id is 1 raw text is: FOOD AND DRUG LAW JOURNAL VOLUME 64 ISSUE 1 2009 CONTENTS R eports to the R eader ...................................................................................................... i Problems Associated with Direct-to-Consumer Advertising (DTCA) of Restricted, Implantable Medical Devices: Should the Current Regulatory A pproach be Changed? ........................................................................ Bruce Patsner I Dietary Supplement Labeling Claims and Advertising: Are Clinical Studies on the Full Product Required? .................... John E. Villafranco 43 Katie Bond Pandemic Influenza: Is there a Corporate Duty to Prepare?... Joseph P. McMenamin 69 Government Regulation of Pricing and Reimbursement of Prescription Medicines: Results of a Recent M ulti-Country Review .................................................................. Richard Kingham 101 Joanna Wheeler No Longer If, But When: The Coming Abbreviated Approval Pathway for Follow-on Biologics ..................................... Jeremiah J. Kelly 115 Michael David Export of Pharmaceuticals and Medical Devices Under the Federal Food, Drug & Cosmetic Act: FDA's Striking Change in Interpretation Post-Shelhigh ......................................... Edward M. Basile 149 Deborah Tolomeo Elizabeth Gluck Analysis of the Impact of the Uruguay Round Agreements Act on Pharmaceutical Patents ....................... Enrique Seoane-Vazquez 171 Rosa Rodriguez-Monguio Sheryl L. Szeinbach Andrew Beyer Jay Visaria FDA's Proposed Regulations to Expand Access to Investigational Drugs for Treatment Use: The Status Quo in the Guise of Reform ...................................................... Benjamin R. Rossen 183 A Legal Duty to Disclose Individual Research Findings to Research Subjects? ................................................................. M atthew P. G ordon 225