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FDA Prepares For LPAD: Orphan Drug Approvals Are Model

 
• By Laura Helbling

One of the bedrock consensus issues throughout the drafting of the “21st Century Cures” legislation has been that the bill should create a pathway for approval of new antibacterials for limited populations – known as LPAD. But what would it actually do?

A limited use approval pathway is one of the more intriguing components of the “21st Century Cures” FDA reform provisions. As the legislation moves to the Senate, FDA is joining other stakeholders to outline its vision for how the new authority would work.

Part of the message is explaining why a pathway that limits an approved indication is actually an incentive for drug...

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