Success Story

Approval for a Product that Fights Drug-Resistant Tuberculosis Using FDA’s LPAD Program

We recently helped one of our clients achieve FDA approval for a product that fights drug-resistant Tuberculosis using FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). We supported our client through all NDA review-period requests for information and scheduled meetings with FDA, and ultimately helped secure priority review for their NDA.

The LPAD program encourages product development for limited populations with serious and life-threatening infections with unmet needs and allows FDA to consider the totality of evidence supporting the efficacy and safety of the product.

Learn more about FDA programs to support drug development in Infectious Disease, including GAIN, QIDP, and LPAD in our article on this topic. Read more >