Reactions 753 - 29 May 1999

■ The US FDA has requested proposals for an activepostmarketing surveillance hospital pilot programmeto evaluate adverse event signals which may be linkedwith drugs or devices, the Pink Sheet reports. Theprogramme will complement the current adverseevent reporting system and help to reduce the timeneeded to identify serious problems associated withdrugs or medical devices. The contractor hired by theUS FDA will create algorithms for adverse eventsignals, such as antidote prescriptions or cancelledprescriptions, which could actively identify adverseevents, and will be required to submit bimonthlyadverse event reports to the FDA. Proposals for theprogramme are due on 8 June.FDA postmarketing active surveillance pilot to study adverse event signals.FDC Reports - Pink Sheet - Prescription Pharmaceuticals and Biotechnology61: 4, 17 May 1999 800765813

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Reactions 29 May 1999 No. 7530114-9954/10/0753-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved