Industry Fears FDA May Monkey With ‘Independent’ Audit of Reviews

Drugmakers worry that the FDA doesn’t plan to conduct an honest review of its new drug review program in an upcoming audit. To head off a whitewashing of the review, PhRMA and BIO are calling on the FDA to confirm the independence of the third-party contractor it will use to audit the new drug review process under the Prescription Drug User Fee Act (PDUFA V). The new review process adds 60 days to the review clock for new molecular entity (NME) NDAs and original BLAs and is supposed to result in more first-cycle decisions for drugmakers.
Washington Drug Letter