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US FDA User Fees

Set Alert for FDA User Fees

US FDA Exploring Furlough Possibility If User Fee Bill Not Enacted In Time

Furloughs would allow affected FDA staff to remain employed, while a layoffs would require affected workers to be rehired.

User Fees Review Pathway

Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023

Senate appropriations bill would take back some of the increase the House offered the Center for Drug Evaluation and Research and other programs, setting up negotiations as next fiscal year nears.

Legislation Neurology

Pink Sheet Podcast: FDA User Fees, Real-Time Oncology Review, ALS Accelerated Approval, Opioid Suit

Pink Sheet reporter looks at the biggest US FDA and pharma industry stories of the week, including the status of US FDA user fee renewal legislation, new real-time oncology review program guidance, Biogen’s ALS accelerated approval play, and Teva settling opioid litigation.

User Fees Review Pathway

US FDA User Fees: Lay-Off Notices Planned For Early September If Congress Doesn’t Pass Bill

The notices normally would go out on 1 August, but unspent user fee funds may be able to sustain work for a few weeks if the program expires.

User Fees Legislation

Don’t Expect Abandonment Of US FDA User Fee Programs If They Sunset

Popular characteristics like goal dates are expected to remain in place if Congress does not renew the user fee programs by 1 October.

User Fees Legislation

FDA’s ‘Imminent Action’ Policy Likely Not Best Path For ANDAs To Address Late Brand Label Changes

The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.

Generic Drugs Drug Review

For ANDAs, Pre-Submission Facility Correspondence Has Improved, But Still Not Ideal

US FDA wants the program, intended to help speed ANDA approvals, utilized more, but industry still questions the information that must be submitted.

Generic Drugs Review Pathway

US FDA User Fee Legislation: Is Sen. Burr’s ‘Clean’ Bill A Lifeline – Or A Wrench In The Works?

Sen. Richard Burr introduces a reauthorization bill without any policy changes, even ones he previously endorsed, saying it’s the clearest path forward now.

User Fees Legislation

Califf Appears To Set 2025 As End Of His Term As US FDA Commissioner

Outlining what changes he wants to see at the agency before he leaves, Califf also worries congressional inaction on the user fee reauthorization could affect hiring efforts.

FDA Leadership

A Bipartisan Case Against US FDA User Fees?

Senators Richard Burr and Bernie Sanders do not typically agree on many issues. But during consideration of the US FDA user fee reauthorization package, both expressed concern that the increasing fees contribute to higher drug prices – and both voted against moving the package forward.

User Fees Pricing Debate

PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short

The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.

User Fees FDA

Candidates For The US FDA’s STAR Program Might As Well Be Breakthrough Therapies, Too

The requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.

Review Pathway User Fees
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