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Expanded Access Opens Window For Dose Optimization Studies In Cancer

 
• By Sue Sutter

The period after completion of pivotal trials but ahead of FDA approval provides an opportunity for oncology drug sponsors to conduct badly needed dose comparison trials, a multi-stakeholder panel says at the annual Conference on Clinical Cancer Research.

The peri-approval period between completion of registration trials and FDA approval of a new cancer medicine presents a “window of opportunity” for conducting dose comparison studies, a multi-stakeholder panel said Nov. 7 at the 2013 Conference on Clinical Cancer Research.

Conducting further dose exploration as part of an expanded access program before drug approval could lead to better information in labeling about the appropriate dose without unduly delaying a drug’s...

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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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