FDA to Hold Public Meeting on Transplant Drugs

As part of its performance commitments under PDUFA V, the FDA has scheduled a Sept. 27 public meeting on patient-focused drug development for individuals who have undergone an organ transplant.

In addition to gaining patient input into treatment approaches, stakeholders will look into scientific challenges for developing candidates to manage organ transplants.

The agency has committed to gaining patient perspectives on 20 disease areas under PDUFA V. Last July, it published the disease areas it would focus on during fiscal years 2016 and 2017 as part of this commitment.

Read the Federal Register announcement of the meeting here: www.fdanews.com/04-27-16-meeting.pdf.