The FDA’s fee for new drugs with clinical data has risen from a little more than $2 million in 2017 to $3.1 million in 2022.
The 2022 fee for FDA approval applications not requiring clinical data will be about $1.6 million in 2022, which is about $200,000 more than the previous two years.
Drugmakers pay these fees to ensure the FDA responds to applications within 10 months for standard applications and within six months for expedited reviews.
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