Tracking Troubled NDAs: New FDA Regs Mean Less Clarity For Investors
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
After an 11-year process, FDA is doing away with “approvable” and “not approvable” letters. The new name (“complete response”) gets rid of the negative connotations of “not approvable.” But it is likely to create more confusion – and less transparency – for investors and the public