William M. Janssen Copyright (c) 2009 All rights reserved. http://works.bepress.com/william_janssen Recent documents in William M. Janssen en-us Sun, 31 May 2009 13:07:05 PDT 3600 A Historical Perspective on Off-Label Medicine: From Regulation, Promotion, and the First Amendment to the Next Frontiers http://works.bepress.com/william_janssen/13 http://works.bepress.com/william_janssen/13 Mon, 20 Apr 2009 21:24:30 PDT In FDLI's principal work on off-label medicine, this Chapter summarizes the evolution of off-label practices (including use, prescription, and promotion), tracks the development of the law on these issues, and discusses the future legal challenges that still await a firm resolution. William M. Janssen Drug & Device Law POST-MARKETING REQUIREMENTS http://works.bepress.com/william_janssen/12 http://works.bepress.com/william_janssen/12 Tue, 06 Nov 2007 22:49:26 PST William M. Janssen Drug & Device Law MONITORING DEVICE PERFORMANCE, ADVERSE EVENTS/PRODUCT PROBLEMS, PRODUCT RECALLS, AND CORRECTIONS AND REMOVALS http://works.bepress.com/william_janssen/11 http://works.bepress.com/william_janssen/11 Tue, 06 Nov 2007 22:48:24 PST William M. Janssen Drug & Device Law PROMOTION & ADVERTISING OF MEDICAL DEVICES http://works.bepress.com/william_janssen/10 http://works.bepress.com/william_janssen/10 Tue, 06 Nov 2007 22:47:33 PST William M. Janssen Drug & Device Law FDA's Independent Drug Safety Board: The Quest To Restore Confidence In FDA's Stamp Of Approval http://works.bepress.com/william_janssen/9 http://works.bepress.com/william_janssen/9 Tue, 06 Nov 2007 22:46:12 PST Co-authored with Royce W. Smith, Esq. of Philadelphia. William M. Janssen Drug & Device Law Ethnic / Race Niche Drugs http://works.bepress.com/william_janssen/8 http://works.bepress.com/william_janssen/8 Tue, 06 Nov 2007 22:44:26 PST This article explores the prudence and legal validity of approaching pharmaceutical development at a level of ethnic and race "niche" products. Co-authored with Royce W. Smith, Esq. of Philadelphia. William M. Janssen Drug & Device Law Group Justice? Legal Moves That Lump Pharma Cases Together Are Bad For Justice And Bad For The Industry http://works.bepress.com/william_janssen/7 http://works.bepress.com/william_janssen/7 Tue, 06 Nov 2007 22:41:23 PST This article critiques the judicial penchant for combining drug and device tort cases together for adjudication, and posits that the functional challenges encountered with such efficiencies compromise the essential truth-finding process of such litigation. William M. Janssen Drug & Device Law Selecting the Jury http://works.bepress.com/william_janssen/6 http://works.bepress.com/william_janssen/6 Tue, 06 Nov 2007 22:36:53 PST A strategic overview of the process of jury selection. Co-authored with Walter R. Milbourne, Esq. of Philadelphia. William M. Janssen Civil Procedure Postmarketing Requirements http://works.bepress.com/william_janssen/5 http://works.bepress.com/william_janssen/5 Tue, 06 Nov 2007 22:34:06 PST This chapter introduces the intricate regulatory scheme of postmarketing regulations that restrict the commercialization of medical devices. Co-authored with Royce W. Smith, Esq. of Philadelphia. William M. Janssen Drug & Device Law Medicine Meets Madison Avenue: The Direct-to-Consumer Advertising of Prescription Drugs http://works.bepress.com/william_janssen/4 http://works.bepress.com/william_janssen/4 Tue, 06 Nov 2007 22:30:13 PST This chapter surveys and analyzes the legal dimensions of advertising prescription medical products directly to consumers. Co-authored with Gregory J. Wartman, Esq. of Philadelphia. William M. Janssen Drug & Device Law