Regulatory Beat: FDA Encourages Innovation in Biotech Manufacturing and Product Development - New research and policies can ensure product quality through the distribution chain - BioPharm

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Regulatory Beat: FDA Encourages Innovation in Biotech Manufacturing and Product Development
New research and policies can ensure product quality through the distribution chain


BioPharm International
Volume 19, Issue 5

FDA deputy commissioner Janet Woodcock regards The List as an evolving document and expects to issue an update of activities underway this summer. One project on the table is an FDA-industry effort to identify biomarkers that already exist to demonstrate the practical value of such measures. FDA participated in an Institute of Medicine workshop on cancer biomarker development in March and plans to hold a workshop on what type of evidence is needed to qualify biomarkers for different purposes. This should lead to a general biomarker qualification guidance which will describe approaches for linking biomarker validation to intended uses. Additional guidances on specific qualified markers will follow, possibly starting with documents on testing for liver and kidney toxicity.

Also on the agenda is draft guidance on drug-diagnostic codevelopment. FDA published a concept paper on this topic in April 2005, but the specifics of developing a diagnostic test to fit a new therapy have been difficult to pin down.

Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634,


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