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Concept Papers Seek Industry Input On Combo Product Issues

This article was originally published in The Gray Sheet

Executive Summary

FDA seeks feedback on two concept papers offering preliminary thoughts on adverse event reporting and on the number of applications needed for a combination product

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Regulatory News In Brief

Bird flu, special controls: Influenza A subtype tests and reagents are officially Class II medical devices following the March 22 release of a final rule and special controls 1guidance document detailing the 510(k) requirements for such products. The Centers for Disease Control & Prevention won clearance for the first rapid H5 subtype test to help identify avian flu cases through an expedited de novo 510(k) application in February (2"The Gray Sheet" Feb. 6, 2006, p. 11). Several firms are developing avian flu tests, including Toronto-based Tm Bioscience...

Regulatory News In Brief

Bird flu, special controls: Influenza A subtype tests and reagents are officially Class II medical devices following the March 22 release of a final rule and special controls 1guidance document detailing the 510(k) requirements for such products. The Centers for Disease Control & Prevention won clearance for the first rapid H5 subtype test to help identify avian flu cases through an expedited de novo 510(k) application in February (2"The Gray Sheet" Feb. 6, 2006, p. 11). Several firms are developing avian flu tests, including Toronto-based Tm Bioscience...

Combination Products Office Urges Companies To Call With Their Questions

FDA's Office of Combination Products recommends that companies struggling with areas for which there is no clear FDA regulation or guidance consult directly with the office's staff

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