Critical Path follow-on biologics projects idle
Executive Summary
FDA Chief Medical Officer Janet Woodcock says there is little interest by industry in follow-on biologics projects under the Critical Path Initiative. "I don't think that we've gotten a lot of partners to work on those different projects, they are not very prominent," she observes. The agency's opportunities list includes two projects - Novel Approaches to Characterizing and Standardizing Biological Products and Enabling Manufacturing Changes for Well-Characterized Proteins - that could clarify underlying scientific issues complicating development of regulatory policy on follow-on biologics (1"The Pink Sheet" April 10, 2006, p. 13)...
You may also be interested in...
FDA Sees Critical Path Opportunity To Address Follow-On Biologics
FDA's Critical Path opportunities list suggests that the agency is actively working to lay the scientific groundwork for follow-on biologics
The Aspirin Test For AI?
US FDA Commissioner Robert Califf tells Congress that regulators don’t have to know how artificial intelligence works in medicine, but must make very sure it actually does work.
Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire
Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.