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The 505(b)(2) application has many advantages, but perhaps the biggest is that it allows sponsors to avoid conducting time-consuming and expensive new clinical trials by using previously published studies and prior FDA findings on safety and effectiveness on similar approved drugs. Sponsors of 505(b)(2)s have to pay a user fee under the Prescription Drug User Fee Act (PDUFA), but in return they get a PDUFA review clock of about 10 months for a standard application and six months for a priority application. By contrast, under the 505(j) ANDA suitability petition process, sponsors would have to wait for the FDA to rule on a suitability petition, then submit the ANDA and wait for the FDA to rule on that application. That process could take 35 months to reach approval.