US FDA Clarifies Populations And Anti-Infective Indications Eligible For Approval Under LPAD

 
• By Sue Sutter

Final guidance on regulatory pathway for antibacterial and antifungal drugs is not substantially different from 2018 draft version but gives more detail on the process for submitting promotional materials prior to dissemination and seeking termination of LPAD labeling limitations.

Outdoor view of a narrow pathway covered by gravel in a public garden. Leading way limited by green scrubs and branches. Natural image in a french park.
US FDA has finalized its guidance on implementation of the limited population pathway. • Source: Shutterstock

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