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How FDA Will Use Its New Authority against Denying, Limiting or Refusing Inspections – And Why Industry is Still Worried

 
• By Bowman Cox

How will FDA use its recently drafted guidance against obstructing inspections? Industry fears it may depend on how individual investigators interpret terms like “reasonable.”

A question raised in the packed Sept. 16 conference session spoke to everyone’s fears about overzealous investigators and how they might use FDA’s new authority to deem product adulterated whenever they believe someone is obstructing their inspection.

Recent warning letters suggest that only extreme cases will trigger FDA’s use of this powerful authority granted by section 707...

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• By Ewan Townsend

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US FDA’s Familiar Drug Pricing To-Do List

 
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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

More from Compliance

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

US FDA’s Familiar Drug Pricing To-Do List

 
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Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

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