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As GDUFA Launch Nears, Is Sitting In The Backlog More Appealing?

 
• By Derrick Gingery

More submissions are going into the generic drug backlog, likely because the backlog fee is expected to be less than half the GDUFA application fee.

FDA’s generic drug backlog has become increasingly popular recently, apparently to save money on user fees.

The agency is understood to be receiving a higher than normal number of submissions, which would be an effort to be in the review queue before the new application fees...

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BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
• By Laura Helbling

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

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.