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CBER, ORA Saw FY 2020 User Fee Spending Drop Even As COVID Strained US FDA’s Resources

 
• By Derrick Gingery

ORA continued to spend user fee dollars despite its inability to travel for facility inspections, while CBER found little generic and biosimilar work during FY 2020.

Financial management
The pandemic forced spending adjustments in several FDA offices during FY 2020. • Source: Alamy

Some centers within the US Food and Drug Administration saw user fee spending decline compared to estimates during fiscal year 2020, in part because of the pandemic, although not in what some may consider a predictable pattern.

The Center for Biologics Evaluation and Research, which became the center of attention amid COVID-19 vaccine development, conducted very little...

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No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By Sue Sutter

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

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EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

US FDA Commissioner Makary Is Learning To Appreciate His Staff

 
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After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
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Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.