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1992 FDLI Update 1 (1992)

handle is hein.journals/fdliup1992 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 1992 Number 1 Route to: Q Q Q Vice President Quayle, Senator Hatch Address 35th Annual Educational Conference Vice President Dan Quayle addressed over 1200 attendees at FDLI's 35th Annual Educational Conference in December. As the featured speakerduring General Session II, the Vice President discussed the issues and activities of the White House Competitiveness Council, which he chairs. Mr. Quaylepointed out that theCouncil has been a leader in regulatory reform, has strived for new developments in the areas of communication and biotechnology and has workedon implementing the Clean Air Act. Just about everything we've tried to do involves, in one way or another, challenging the federal bureaucracy and questioning the status quo, he stated. He reminded the audience, consisting of professionals from industry, government and the private bar, that it was important to create new technology and develop new thinking about the future. In This Issue Calendar of Events 2 New Members 4 Device Promotion 5 FDCL Journal 6-7 Recommended Publications 7 People On The Move 10 Job Exchange 11 President Bush 12 We have deliberately meshed FDA veterans with relative newcomers -- the old with the new --and this constellation is a part of our overall strategy for repositioning the agency, stated FDA Commissioner, Dr. David Kessler atFDLI's 35th Annual Educational Conference. Players in his newly-appointed senior management team include Michael Taylor, Deputy Commissioner for Policy, whose mission is to make FDA base its work on Digitized from Best Copy Available Pictured above: Vice President Dan Quayle Pictured left: Senator Orrin Hatch (R-Utah) The Vice President discussed the drug approval process and compared the FDA to those institutions thatare analogous in other industrialized nations. He stated that most of these agencies approve drugs faster, and do it without compromising standards for safety, efficacy and quality. That leads reasonable minds to believe America can do better, he stated. Mr. Quayle announced, after collaborating with Secretary for Health and Human Services, Dr. Louis Sullivan, and FDA Commissioner, Dr. David Kessler, a set of reforms that will reduce the average development time for promising therapies by 40 percent. His three methods of achieving this goal are through accelerated drug approval wherever possible, through a sound policy to benefit the consumer; Carol Scheman, Deputy Commissioner for External Affairs, who will effectively communicateFDA's message; Elkan Blout, Ph.D., Senior Advisor for Science, who will strengthen science capabilities and draw on outside expertise; Mary Jo Veverka, Senior Advisor for Managementand Systems, who says business as usual isa luxury FDAcan Continued on page 3 Continued on page 3 Kessler Discusses New, Old-Fashioned FDA

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