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GPhA’s Goals For 2013: Smooth GDUFA Implementation, Workable Biosimilar Pathway

 
• By Sue Sutter

The generic drug trade association’s cross-cutting priorities are the result of an extensive strategic planning process, CEO Ralph Neas says; the group is planning outreach to Congress and the executive branch to highlight the role generic drugs can play in helping to address the nation’s fiscal problems.

The Generic Pharmaceutical Association is heading into its annual meeting in Orlando, Fla. with a new strategic plan focused on a host of cross-cutting regulatory, policy, legislative and legal issues, as well as goals for growing its organizational revenues, membership ranks and internal staff in the coming year.

The group’s 2012 annual report, which will be released in connection with the Feb. 20-22 meeting, reflects a new level of strategic planning for an organization whose operations are decidedly...

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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.

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