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ANDA Approval Speed-Up Leaves Sponsors With Less Margin For Error

 
• By Derrick Gingery

Get applications in right, or get a complete response letter, FDA says; firms will have fewer opportunities for mid-review application corrections as review goals reach 10 months.

Generic drug sponsors may be excited for the upcoming possibility of gaining an ANDA approval in less than a year, but with the increased speed will come a smaller window for mid-review corrections.

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• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

Makary’s Reorganization Decision A Turning Point For US FDA?

 
• By Michael McCaughan

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Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

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

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.