We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Pledges Clearer Biomarker Guidance Amid Industry Criticism
FDA Pledges Clearer Biomarker Guidance Amid Industry Criticism
August 18, 2006
The FDA is pledging to clarify its final guidance for premarket approval and 510(k) premarket notification applications of biomarker tests, while rejecting industry criticism that the agency’s approach is overly burdensome, an agency official said.