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ANDA Yo-Yo: FDA Receives Second-Lowest Submission Count In October After September Bolus

 
• By Derrick Gingery

The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.

ANDA submissions dropped dramatically from a 140 in September to 14 in October. (Shutterstock)
Key Takeaways
  • The 14 ANDAs submitted in October were the second-lowest monthly total in the GDUFA era.

The aftermath of an ANDA avalanche hit the US Food and Drug Administration in October, even though the actual crush...

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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• By Derrick Gingery

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Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
• By Neena Brizmohun

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• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.