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PDUFA Negotiations End With Differences To Resolve In Commitment Letter

 
• By Derrick Gingery

The entire PDUFDA VI reauthorization process likely is more than a year from completion, but agreeing on a draft commitment letter is a major milestone for FDA and the pharma industry. It will serve as the foundation of the legislative phase expected to begin in early 2017.

Negotiations on re-authorizing the Prescription Drug User Fee Act are completed, but it appears that industry and likely FDA are continuing to vet the draft commitment letter for final approval.

Both FDA and industry agreed Jan. 29 to take the draft commitment letter and proposed statutory changes to their senior management for ratification, according to minutes of the...

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More from United States

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

More from North America