April 12, 2018 / 4:34 PM / in 9 days

BRIEF-FDA Advances Policy To Make Development Of Drugs & Diagnostics In Cancer Trials More Efficient

April 12 (Reuters) - U.S. Food and Drug Administration:

* FDA ADVANCES POLICY TO MAKE CO-DEVELOPMENT OF DRUGS AND DIAGNOSTICS IN CANCER TRIALS MORE EFFICIENT

* FDA SAYS IS STREAMLINING AGENCY’S REVIEW OF CANCER DIAGNOSTICS THAT ARE DEVELOPED IN CONJUNCTION WITH DRUG TRIALS

* ISSUING DRAFT GUIDANCE FOR CERTAIN ONCOLOGY TRIAL SPONSORS WITH OPTIONAL STREAMLINED SUBMISSION PROCESS REGARDING USE OF INVESTIGATIONAL IN VITRO DIAGNOSTIC

* OPTIONAL SUBMISSION PROCESS DETERMINES WHETHER USE OF IVD IN CANCER TRIALS IS CONSIDERED SIGNIFICANT/NON-SIGNIFICANT RISK OR EXEMPT FROM FURTHER REVIEW Source text: (bit.ly/2Hw1VYA)

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