Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.
|Articles|January 15, 2003
- BioPharm International-01-01-2003
- Volume 16
- Issue 1
Inside Washington: Coverage and Consolidation ? Key Issues for Biotech Companies
Author(s)Jill Wechsler
by Jill Wechsler Manufacturers are concerned about congressional efforts to establish a Medicare pharmacy benefit and to regulate research while FDA shifts regulation of biologics and other drugs.
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Biotech World: Canada's Supreme Court says "No" to Harvard Mouseover 23 years ago
Guest Editorial: At the Governance Crossroadover 23 years ago
Reducing Costs by Facility Designover 23 years ago
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