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Can Real-World Evidence Be Used To Remove LPAD's Limited Population Designation?

 
• By Michael Cipriano

Antibiotic sponsors wonder whether RWE would be sufficient to convert a product to full approval. Ahead of US FDA's public meeting on the LPAD guidance, industry has a number of lingering questions.

Antibiotic resistant bacteria closeup biofilm
The US FDA will hold a public meeting on the LPAD draft guidance on 12 July.

Can real-world evidence be sufficient to support a supplemental application for lifting the restrictions of the 21st Century Cures Act's limited population antibacterial drug (LPAD) pathway? Or would a clinical trial be required?

These are among the many questions industry has raised about LPAD as the US Food and Drug Administration readies for a 12 July public meeting on the subject. The agency will specifically be hearing comments on the June 2018 draft guidance before it finishes finalizing it

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