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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?


To: appro who wrote (670)12/29/1997 3:16:00 PM
From: Czechsinthemail  Respond to of 887
 
I'm wondering how the revised FDA regulations for off-label use might impact DEPO. If the assumption is correct that the crossbar may be somewhat easier to clear for DepoCyt for leukemia and lymphoma-related NM, could relaxed off-label regs make it possible to expand off-label use for solid tumor and other indications?
Also, since this provision is scheduled for 1998, does anyone have any thoughts about how this may affect new drug applications going forward e.g. looking toward the easiest approval rather than the biggest market for a new drug, then adding other indications as off-label uses.
Baird