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Antibiotic Stakeholders Discuss Ethics Of Testing Limited Population Drugs In Broader Populations

 
• By Michael Cipriano

The US FDA's LPAD draft guidance suggests that clinical trials for potential limited population antibacterials would enroll broader patient populations. But is that an ethical approach?

Antibiotic-resistant-bacteria
The US FDA held a public meeting 12 July to solicit comments on its LPAD draft guidance.

With an endorsement of non-inferiority trials in its June 2018 draft guidance on the limited population antibacterial drug (LPAD) pathway, the US Food and Drug Administration suggests that clinical trials for such drugs will include a broader patient population than that described by the labeled indication.

But is such an approach ethical? Stakeholders offered competing takes on the question at a 12 July public meeting on the draft guidance.

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