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1991 FDLI Update 1 (1991)

handle is hein.journals/fdliup1991 and id is 1 raw text is: The Food and Drug Law Institute UPDATE Promoting an understanding of the laws and regulations administered by FDA Volume 9, No. 1 January/February 1991 Frank Duckworth Retires, John Villforth Elected FDLI President in December The 34th Annual Educational Conference was opened with the announcement of Frank Duckworth's retirement as President of FDLI. Mr. Duckworth has spent five years expanding the Institute by offering a more diverse scope of seminars in greater number, by publishing books and directories for FDLI members; and by increasing membership. Mr. Duckworth was also instrumental in developing workshops on the international level to teach FDLI member companies with European subsidiaries how to comply with S. food, drug and medical device Regulations. Under Frank Duckworth's presidency, FDLI expanded to offer publications which included relevant court decisions and regulations; many of these decisions were not published by any other organization. Upon his retirement, Mr. Duckworth has continued to fulfill the need of educating industry by establishing his own company, FD Inc. He developed the company to provide data retrieval services for pertinent cases, decisions and regulations using the latest technology, a CD-ROM data base. FD Inc. now employs five professionals in the food and drug field and is located in Washington, DC. In This Issue Enforcement Workshop 2 Food Update Information 3 New Members 4 Expanded Membership Benefits 5 FDCL Journal 5-7 1991 Tear-out Meeting Schedule 9 Recommended Books 13 People On The Move 14 Job Exchange 15 Villforth Looks To The Future In the past, FDLI has held its seminars primarily on the East Coast. The Institute began 1991 by offering seminars on a regional level due to a growing awareness of the recent constraints on travel. The first meetings will be held in Orange County, California and will discuss current issues relating to Institutional Review Boards and Informed Consent on February 26th and How to Deal with FDA's New Enforcement Initiatives on February 27th. These seminars will focus on both regional and national issues faced by medical device and pharmaceutical companies located on the West Coast. March will take FDLI to Chicago to teach industry within the region how to deal with FDA's new enforcement initiatives. The meeting will be held on March 25th. Philadelphia has been selected to hold a regional inspections workshop designed for Commissioner Delivers In an opening address to over 1,300 attendees at FDLI's 34th Annual Educational Conference, Commissioner David A. Kessler, M.D. called for a boldness of thought with regard to opportunities that the Agency faces. He has asked each of the Agency's Center Directors to devise new agendas containing bold and dynamic approaches. Dr. Kessler stressed that FDA must foster a sense of leadership at all levels. It is only when Center Directors and their Digitized from Best Copy Available northeastern industry and will be held on April 5th. The Institute is also publishing Food and Drug Law, a comprehensive sequel to the Seventy-Fifth Commemorative Volume of Food and Drug Law previously published by FDLI. As a service to members, publication of the ten new regulations will also be offered in the spring, along with an updated edition of the FDA Directory. A First Address To FDLI managers feel they have the authority to act that they can fairly be held accountable, he commented. In his speech, the Commissioner defined five priorities. The first was the restoration of FDA's credibility following the generic drug scandal. Until and unless we have done everything possible to prevent misconduct in the future the Agency cannot restore its integrity. Continued on page 2 N

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