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Enhanced Sample Multiplexing of Tissues Using Combined Precursor Isotopic Labeling and Isobaric Tagging (cPILOT)
Published on: May 1, 2017
FDA pilot programme in support of global harmonisation
1Donawa & Associates Ltd., Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
Abstract:
Imagine having one document that would demostrate the conformity of a medical device with regualtory requirements worldwide. Although it may be some time before this goal is reached, the United States Food and Drug Administration is launching a premarket review pilot programme in support of global harmonisation. This article discusses the programme and why European manufacturers should consider participating.
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