FDA “Limited Use” Approval Pathway Gains Traction in Congress

Sens. Michael Bennet, D-Colo., and Orrin Hatch, R-Utah, signal Congressional revival of the Limited Population Antibacterial Development Program, offering antibiotics as the guinea pig for a potentially broader “limited-use” pathway.

Legislators are interested in reviving efforts to create a new regulatory pathway that would allow for the fast approval of drugs for subpopulations that address serious or life-threatening conditions with unmet medical need and suggest the agency start with antibiotics, an April 23 letter to FDA Commissioner Margaret Hamburg indicates.

Sens. Michael Bennet, D-Colo., and Orrin Hatch, R-Utah, said they support such a pathway, which could encourage investment in treatments...

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