pdufa-related changes have led to pharmaceutical companies targeting more drugs for first launch in the united states thus increasing patient access to new medicines. faster drug review from 1990 to 2001 were found to increase the probability of a drug being launched first in the united states by 14%. other changes made under pdufa such as the increased probability of approval and shortened development periods increased the probability of a drug being first launched in the united states by 31 percent at the end of pdufa i and 27 percent at the end of pdufa ii. during the eight years before pdufa took effect, an average of 24 new drugs were approved each year. the number of approvals ranged from 20 in 1988 to 30 in 1991. during the four years that pdufa i was in effect, an average of 32 drugs were approved each year, ranging from 22 in 1994 to 53 in 1996. the average number of new drugs approved by the fda each year increased by one-third. first drug launches making use of new chemical entities in the united states increased from 44 from 1982 through 1992 to 156 in from 1993 through 2003 period. the increase in first drug launches in the united states from 1993 through 2003 is particularly interesting given that the european union harmonized its regulatory regime for new drugs with those of other major markets in order to reduce barriers for drug approvals during the same period. regulator-industry communication david kessler described improved communication between the fda and the drug industry on what data should be included in ndas as an important benefit of pdufa. he said, "for example, in fiscal year 1993, 34 of the new applications that came into the fda were sent back to the company because they were poorly prepared or missing critical information. in fiscal year 1996 six applications were refused for these reasons – a more than fivefold improvement." pdufa dates pdufa dates are deadlines for the fda to review new drugs. the fda is normally given 10 months to review new drugs. if a drug is selected for priority review, the fda is allotted 6 months to review the drug. these time frames begin on the date that an nda is accepted by the fda as complete. scale of fees fda calculates fees based on an annual basis. for fiscal year 2021, drug application fees are: $3,117,218 per full application requiring clinical data, $1,558,609 per application not requiring clinical data or per supplement requiring clinical data. $369,413 for programs the fda estimates that operating costs for the year 2017 will be $878,590,000. the fd&c act specifies that one-third of the total fee revenue is to be derived from application fees, one-third from establishment fees, and one-third from product fees (see section 736(b)(2) of the fd&c act). fda estimates that in 2016, 2,646 products will have been billed for product fees and 523 establishments will have been billed for establishment fees. in 2015, 132.5 full application equivalents (faes) were charged an application fee. faes are calculated by counting a full application as one fae and an application not requiring clinical data or a clinical data supplement as half an fae. an application that is withdrawn, or refused for filing, counts as one quarter of the original fae. for a full application this is one quarter fae, and for an application without clinical data or a clinical data supplement this is an eighth of an fae. fda budget user fees imposed under pdufa are expected to add $707 million to the fda budget in 2011, roughly a quarter of the agency's total spending. user fees cover roughly 65 percent of the drug approval process.