FDA Extends Deadline For Continuous Marketing Application Pilot 2 Again
This article was originally published in The Pink Sheet Daily
The agency is accepting applications for the fast-track IND pilot program until Dec. 31. Applications will only be accepted by those divisions of the drug and biologics centers that have not previously selected a Pilot 2 application.
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Selection for the continuous marketing application program could expedite review of the amyloidosis treatment, which is targeted for NDA filing in 2005. The pilot 2 program builds upon an earlier collaboration between Neurochem and FDA through which the agency provided funding for a Fibrillex Phase II/III clinical trial.
The wet age-related macular degeneration product will have a mid-December user fee date; an advisory committee is set for August. The NDA was submitted in “reviewable units” under FDA’s pilot program.
The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.