fda's adr rule partially on hold

Reactions 551 - 20 May 1995 FDA’s ADR rule partially on hold Several sections of the US FDA’s proposed rule on adverse event reporting * will be ‘held in abeyance’ until the International Conference on Harmonisation (ICH) finalises its guidelines, according to a report in the Pink Sheet. The sections to be ‘held in abeyance’ include IND safety reporting, clinical trial design and periodic postmarketing reports. The FDA plans to implement the sections of the proposed rule dealing with definitions and standards for expedited reporting of adverse events. * See Reactions 527: 2, 12 Nov 1994; see Reactions 527 p2; 800325469 FDA adverse event reporting proposal will be partially held in abeyance until ICH harmonizes guidelines; expedited reporting standards will go forth. FDC Reports - Pink Sheet - Prescription Pharmaceuticals and Biotechnology : 7-8, 8 May 1995 800359485 1 Reactions 20 May 1995 No. 551 0114-9954/10/0551-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: FDA's ADR rule partially on hold

Reactions 551 - 20 May 1995

FDA’s ADR rule partially on holdSeveral sections of the US FDA’s proposed rule on

adverse event reporting* will be ‘held in abeyance’ untilthe International Conference on Harmonisation (ICH)finalises its guidelines, according to a report in the PinkSheet.

The sections to be ‘held in abeyance’ include INDsafety reporting, clinical trial design and periodicpostmarketing reports. The FDA plans to implement thesections of the proposed rule dealing with definitionsand standards for expedited reporting of adverse events.* See Reactions 527: 2, 12 Nov 1994; see Reactions 527 p2;800325469

FDA adverse event reporting proposal will be partially held in abeyance until ICHharmonizes guidelines; expedited reporting standards will go forth. FDC Reports -Pink Sheet - Prescription Pharmaceuticals and Biotechnology : 7-8, 8 May1995 800359485

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