USA – LPAD pathway: FDA finalizes guidance

The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.
 
The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited population pathway for antibiotics in new guidanceRegulatory Focus 13 June 2018).
 
Much of the guidance remains unchanged from the draft version, though FDA has made clarifications and added examples throughout the document.
 
In the final guidance, FDA further clarifies how it interprets “limited population” by contrasting two examples of drugs, one that would be fit for the LPAD pathway and one that would not…