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FDA “Progressive Approval” And “Exceptional Approval” Pathways Possible Under Senate Bill

 
• By Derrick Gingery

Legislation being drafted by Sen. Kay Hagan, D-N.C., would formalize FDA practices of approving drugs in certain circumstances where the evidence needed for a standard approval cannot be generated.

A bill awaiting introduction in the Senate would create two new approval mechanisms for FDA.

Progressive and Exceptional approval, as they are named in draft bill, would essentially codify existing FDA practices of allowing drugs in certain cases to

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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
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The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

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