BioCentury | Aug 11, 2014
Regulation

LDT blurred Lines

FDA's release of draft guidance in a congressional notice officially put down a marker on the agency's plans for a risk-based framework for regulating laboratory-developed tests. Some stakeholders think the proposed oversight could better align...
BC Week In Review | Oct 9, 2006
Clinical News

EGFR pharmDx kit regulatory update

FDA approved a PMA for Dako's EGFR pharmDx kits to assess patient eligibility for Vectibix to treat colorectal cancer. Vectibix panitumumab is marketed by Amgen Inc. (AMGN, Thousand Oaks, Calif.). Dako's test already is approved...
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