Moving Biomarkers To General Acceptance: CDER's Pathway For Biomarker Qualification
With the review of the PSTC's nephrotoxicity biomarker submission, CDER is testing out its pilot pathway for qualifying specific biomarkers for specific applications. Once qualified, a biomarker "would be accepted across all clinical divisions of FDA," Federico Goodsaid of CDER's Office of Translational Sciences noted at the DIA annual meeting in Atlanta.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth