The priority review fee is due when the application is submitted
Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, section 6604, Sec. 6604.
Written by .
The priority review fee is due when the application is submitted
The document says “shall”Who acts: drug and biological product sponsorsHow: statuteSec. 6604 in the PDF
What the document says
“``(A) In general.--The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1) or section 351(a) of the Public Health Service Act for which the priority review voucher is used. All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law.''.”
Subsection (b) of section 6604 replaces section 529(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act. The priority review user fee is due when the application for which the voucher is used is submitted, and other user fees are due as the Secretary or other law requires.
What the document actually says
“``(A) In general.--The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1) or section 351(a) of the Public Health Service Act for which the priority review voucher is used. All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law.''.”
That sentence, in plain words
The fee for a fast review is due when the application goes in. Other fees are due as the health chief or other law says.
What this is about
A fast review costs the agency more work. The maker pays for it. This says the money comes at the start.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
Consolidated Appropriations Act, 2026, Public Law 119-75, sec. 6604, 140 Stat. 699 (2026). https://www.govinfo.gov/content/pkg/PLAW-119publ75/html/PLAW-119publ75.htm
This page
“The priority review fee is due when the application is submitted,” Consolidated Appropriations Act, 2026, section 6604, Sec. 6604. Read the Mandate, https://readthemandate.org/consolidated-appropriations-act-2026/proposal/sec6604-user-fee-timing/ (retrieved August 26, 2026).
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