The FDA is issuing two guidances of interest to lab test makers, one that finalizes guidance on companion diagnostics used with certain drug treatments and one that announces FDA's intent to more comprehensively regulate "home-brew" or laboratory-developed tests, which previously had little to no scrutiny of their accuracy and reliability.
The Healthy Skeptic is a website about the health care system, and is written by Kevin Roche, who has many years of experience working in the health industry. Mr. Roche is available to assist health care companies through consulting arrangements through Roche Consulting, LLC and may be reached at [email protected].
The Healthy Skeptic is a website about the health care system, and is written by Kevin Roche, who has many years of experience working in the health industry. Mr. Roche is available to assist health care companies through consulting arrangements through Roche Consulting, LLC and may be reached at [email protected].
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