FDA Weighs Special Medical Use Pathway As Legislative Activities Continue

FDA Weighs Special Medical Use Pathway As Legislative Activities Continue-insidehealthpolicy: FDA's new effort to establish a new limited use drug approval pathway -- one mimicking the Limited Population Antibacterial Drug approval mechanism floated during user fee debates last year -- is viewed by many stakeholders as a way to supplement legislative efforts to set up an LPAD scheme. FDA next month will hold a public meeting to gather input on a “potential new pathway to expedite” the development of drugs limited to smaller populations that address unmet medical needs.