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FDA touts strong GDUFA timeliness and reiterates generics' role in lowering drug costs
Summary
The presenter said OPQ and OGD maintained strong GDUFA assessment performance—over 90% on-time completion for original ANDAs and amendments—and closed by noting generics account for about 90% of U.S. prescriptions but only 13% of drug spending, saving Americans roughly $3 trillion over the past decade.
An FDA presenter highlighted recent performance under the Generic Drug User Fee Amendments (GDUFA), saying the agency achieved "over 90% on time completion for original ANDA submissions and amendments as well as GDUFA controlled correspondence." He presented expanding capacity and leveraging innovation as strategies used to sustain that performance.
Closing the forum, the presenter emphasized the public-health importance of generic medicines, stating that generics represent about 90% of U.S. prescriptions while accounting for roughly 13% of prescription spending, and he said generics produced more than $3,000,000,000,000 in savings for Americans over the past decade.
