Snapshot

The Limited Population Pathway for Antibacterial and Antifungal Drugs pathway has been developed by the US Food and Drug Administration of United States.

This pathway can be used where Section 506(h)(1) of the FD&C Act provides that FDA may approve an antibacterial or antifungal drug, alone or in combination with one or more other drugs, under the LPAD pathway, if the following apply: the drug is intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs; the standards for approval under section 505(c) and (d) of the FD&C Act (21 U.S.C. 355) or the standards for licensure under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), as applicable, are met; and FDA receives a written request from the sponsor to approve the drug as a limited population drug. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Info not found