FDA’s final guidance on in vitro companion diagnostic devices, posted July 31, does not include any big changes from the 2011 draft, but the agency’s parallel unveiling of a planned framework for regulating laboratory-developed tests provides some significant new context.
The companion diagnostic document is intended to provide basic guidelines on submissions and approvals for diagnostics that are considered “essential” for the use of companion drugs and, thus should typically be approved simultaneously with a drug
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