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3D Printing And The First Amendment: What A Gun Rights Case Could Mean For US FDA

 
• By Michael McCaughan

A landmark legal case over 3D-printed guns doesn’t involve FDA – but it is worth considering how the issues are likely to apply to the drug approval process in years to come. The right to bear arms may rely on the Second Amendment, but the key for FDA is how courts look at the First Amendment in the context of new technology.

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US FDA's stakeholders have plenty to think about when it comes to new technology.

The US FDA has a famously sweeping mandate, which the agency estimates encompasses 20 cents on every dollar of consumer spending.

Regulation of firearms, however, is safely outside FDA’s jurisdiction. So there may seem to be no reason for FDA (or its many outside constituents) to pay undue attention to a...

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Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

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

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• By Michael McCaughan

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More from Agency Leadership

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.