Drugmakers Seek More Details on LPAD Pathway Draft Guidance

Merck and GlaxoSmithKline called for more information from the FDA in comments on the agency’s draft guidance for sponsors using the limited population pathway for antibacterial and antifungal drugs (LPAD).

The pathway allows for faster, smaller and less-expensive clinical trials for drugs intended to treat serious or life-threatening infections in a limited population of patients with unmet needs.

Merck urged the agency to offer more examples of drugs that may be appropriate for the LPAD pathway.