us fda aiming to improve advisory committee processes

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Inpharma 1549 - 5 Aug 2006 The US FDA is aiming to improve the ability of its advisory committee processes to provide timely, expert opinion to the administration and to reassure the public regarding the integrity of the process. As part of this augmentation process, the FDA plans to clarify the conditions under which conflict of interest waivers are granted and specify when such waivers will be disclosed to the public along with what information will be made available. It also intends to specify when briefing materials used at advisory committee meetings will become open to the public, with wider public dissemination of advisory committee schedules planned. Furthermore, the FDA is looking at implementing a more streamlined approach to the appointment of members to the agency’s drug-related committees. FDA. FDA Announces Plan to Strengthen Advisory Committee Processes. Media Release : 24 Jul 2006. Available from: URL: http:// www.fda.gov 809066085 1 Inpharma 5 Aug 2006 No. 1549 1173-8324/10/1549-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: US FDA aiming to improve advisory committee processes

Inpharma 1549 - 5 Aug 2006

■ The US FDA is aiming to improve the ability of itsadvisory committee processes to provide timely,expert opinion to the administration and to reassurethe public regarding the integrity of the process. Aspart of this augmentation process, the FDA plans toclarify the conditions under which conflict of interestwaivers are granted and specify when such waiverswill be disclosed to the public along with whatinformation will be made available. It also intends tospecify when briefing materials used at advisorycommittee meetings will become open to the public,with wider public dissemination of advisory committeeschedules planned. Furthermore, the FDA is looking atimplementing a more streamlined approach to theappointment of members to the agency’s drug-relatedcommittees.FDA. FDA Announces Plan to Strengthen Advisory Committee Processes.Media Release : 24 Jul 2006. Available from: URL: http://www.fda.gov 809066085

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Inpharma 5 Aug 2006 No. 15491173-8324/10/1549-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved