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Novartis Opts For OTC Recall, With J&J/McNeil Lessons Still Fresh

 
• By Dan Schiff

After shuttering its Lincoln, Neb., OTC facility, the firm recalls some lots of Bufferin, Excedrin, Gas-X and NoDoz. FDA found a “pattern of problems” when inspecting the plant in 2011, and Novartis’ actions suggest it seeks to avoid the same scrutiny that Johnson & Johnson’s OTC recalls elicited.

Novartis Consumer Health Inc. voluntarily recalled some lots of Excedrin pain reliever and other OTC products in hopes of minimizing the damage from quality control failures at its Lincoln, Neb., production facility.

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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.