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FDA Watch: Why the New NGS Guidance May Be a Paper Tiger
From - Laboratory Industry Report
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing…
From - Laboratory Industry Report
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing…
From - National Intelligence Report
Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address…
From - Laboratory Industry Report
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing…
From - National Intelligence Report
One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the…
From - Laboratory Industry Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…