In Vitro Diagnostics
This article was originally published in SRA
US IVD manufacturers asked for comment on the burden of information collection
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.