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US FDA User Fees

Set Alert for FDA User Fees

After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?

Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.

User Fees Legislation

Next US FDA Generics Leader Must Have ‘Frank Conversations’ With Colleagues, Industry, Former OGD Director Says

Susan Rosencrance, who helped negotiate GDUFA III, will take over as acting director of the Office of Generic Drugs following Sally Choe’s departure on 8 October. Former OGD head Uhl says the director needs to be the ‘number one advocate for the generic drug program inside the agency.’

Generic Drugs Leadership

Pink Sheet Podcast: Finally, A US FDA User Fee Deal, ‘Pandemic Is Over’ Take-Aways, Tpoxx Development Issues

Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.

User Fees Coronavirus COVID-19

Will US FDA User Fee Deal Allow BsUFA Reg Science Research To Start?

The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.

Biosimilars User Fees

Pink Sheet Podcast: A September To Remember For US FDA, Plus New COVID-19 Boosters And Opioid Plan

Pink Sheet reporters and editor discuss the emergency use authorization for the updated COVID-19 vaccines, the new FDA Overdose Prevention Framework, and key decisions and deadlines upcoming in September.

Coronavirus COVID-19 Legislation

A Pivotal September For US FDA And Commissioner Califf

The month of September will be a crucial time for the US Food & Drug Administration and the legacy of its commissioner, Robert Califf. The agency will be taking several significant regulatory actions – but also crossing its fingers that legislation to assure its funding is secured.

Leadership Advisory Committees

Drug Pricing And User Fees: CBER Will Need To Build Up As Gene Therapies Become More Popular

A quickened shift toward gene therapies for small populations may be the result of the new Medicare drug pricing law given protections afforded to those types of products.

United States BioPharmaceutical

US FDA’s Biosimilars Group Will Conduct Some Supplement Reviews, Become ‘Like Another Discipline’

Office of Therapeutic Biologics and Biosimilars Director Sarah Yim says in an interview with the Pink Sheet that more staff are being added to deal with labeling supplements.

Biosimilars Review Pathway

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
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