Legislation - G2 Intelligence

FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies

by Glenn S. Demby | Aug 14, 2017 | Essential, FDA-lir, Laboratory Industry Report

From - Laboratory Industry Report
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a…

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FDA Watch: User Fees Dodge a Bullet, a Cancer Drug Approval Breaks New Ground and the Supreme Court Serves Up a Biosims Blockbuster

by Glenn S. Demby | Jul 10, 2017 | Essential, FDA-lir, Laboratory Industry Report

From - Laboratory Industry Report
The FDA budget pot continues to boil. In March, the Trump administration proposed a controversial provision to double the medical user fees that diagnostics, medical device and…

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