PDUFA Why PDUFA was established
There was a time when the drug approval process was even more drawn-out than it is today. Prior to PDUFA, pharmaceutical companies had to wait even longer to bring new drugs to the market, and for every month of delays, drug manufacturers stood to lose millions. The FDA, meanwhile, needed additional manpower to expedite the approval process but was lacking the funds to expand its staff. PDUFA was introduced to remediate this problem. Once passed, the FDA could begin collecting fees from applicants with the understanding that said fees would be used to speed up the drug review process. The FDA also agreed to commit to certain target dates as part of the process.
PDUFA dates
Under PDUFA, the FDA is usually given 10 months to review a new drug application. However, if a drug is designated for priority review, the FDA is given six months to review that drug.
Only a select number of drugs are deemed eligible for priority review. Typically, those given priority represent significant medical breakthroughs or offer treatment where few or no other options exist. Priority review is often granted to drugs that aim to treat serious medical conditions, though drugs that treat less serious conditions are also eligible for priority review if they meet the aforementioned criteria. Review deadlines begin on the date that a new drug application is accepted by the FDA.
Though the FDA generally tries to adhere to PDUFA dates, they aren't set in stone, and it's not unheard of for the FDA to extend a PDUFA date. This generally happens when the FDA needs more time to complete the review process because of a major amendment in a new drug application.