Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need: Live Twitter Feed

4 Feb 2013
Alison Buki

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on the Limited Population Antimicrobial Drug (LPAD) approval pathway – a potential new mechanims to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. The drug’s safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, well-defined subpopulations in which the drug’s benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages.

Read our account of an earlier conference on LPAD hosted by The Pew Charitable Trusts.

 

Thanks to those who followed our live-tweet. Check back at a later date to view a recording of the meeting.

Antibiotic Resistance