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The US FDA will hold a public meeting on the LPAD draft guidance on 12 July.

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