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1990 FDLI Update 1 (1990)

handle is hein.journals/fdliup1990 and id is 1 raw text is: The Food and Drug Law Institute UPDATE Volume 8, No. 1 February/March 1990 33rd Annual Educational Conference Over 1200 Attendees .. . joined together to make FDLI's 33rd Annual Educational Conference a valuable learning experience. Government, industry, academia, press and public interest representatives exchanged information and perspectives at the J.W. Marriott Hotel on December 12th and 13th in Washington, DC. Over 100 speakers assisted in unfolding a carefully planned, comprehensive agenda. Topics ranged from oversight and investigations to current issues in biologics and drugs. Fifteen breakout sessions occurred in a two-day period. The Institute was particularly proud to commence the meeting with a general session which featured DHHS Secretary uis W. Sullivan; then-FDA Commissioner Frank E. Young, FDA Wief Counsel Margaret Jane Porter; DHHS General Counsel Michael J. Astrue; Inspector General Richard P. Kussemw; Schering- Plough President and Chief Operating Officer Richard J. Kogan; and Wayne L. Pines, Executive Vice President of Burson-Marsteller. The Food and Drug Law Institute would like to thank the FDA for co-sponsoring the seminar and to also thank attendees, speakers, the eleven planning committees and the FDA staff for making the 33rd Annual Educational Conference a fantastic meeting! Inspector General Richard Kusserow (left) and HHS General CounselRichard Astrue address attendees at the Annual Meeting. L FD AW RNSTE Attendees listen to Secretary Louis Sullivan's opening address. Upcoming Events FDA's Reproposal on Health Messages March 21, 1990, Ramada Renaissance Hotel, Washington, DC FDA's reproposed rule on health messages is here... 17 pages in the Federal Register on February 13th. If you have anything to do with health claim labeling, this FDLI seminar is for you. FDA officials will explain the background, intent and purpose of the reproposed rule, and representatives of industry, states and other government agencies will present their reactions. The panelists, including FDA officials, will be present for two extended question and answer sessions. IRBs & Informed Consent March 22, 1990, Omni Shoreham Hotel, Washington, DC Clinical investigations of drugs, devices and biologics have grown sharply in recent years. These investigations must comply with Food and Drug Administration's patient informed consent and institutional review board (IRB) regulation. Be sure not to miss this one-day workshop to understand how sponsors can meet these requirements. Featured topics include new IRB and informed consent issues such as studying AIDS products, potential new FDA regulations, product liability and expanding access to therapies. An in-depth case study using a sample informed consent form will be discussed. Digitized from Best Copy Available I L, V -v

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