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| Guidance on In Vitro Companion Diagnostics |
| 07/14/2011 |
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Federal Register Notice: FDA is making available a draft guidance, In Vitro Companion Diagnostic Devices. It is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device for its safe and effective use or an in vitro diagnostic device that is intended for use with a corresponding therapeutic product and included in the instructions for use in the labeling of those products. To download this guidance, click here. To view this notice, click here. |
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