病人集中ed Drug Development (PFDD)

What is Patient-Focused Drug Development?

Patient-focused drug developmentis an ongoing initiative by the U.S. Food and Drug Administration (FDA).PFDD meetings是一种帮助通知FDA不什么rtant to patients about drug development including:

• their experiences;
• their perspectives;
• their needs;
• their priorities.

The FDA uses these insights to inform the drug development and evaluation process.

Initially,the FDA organized these meetings.The FDA now invites patient groupsto organize these meetings.

Patient groups petition the FDA to organize externally-led PFDD meetings. Patient groups then hold a public meeting to share with the FDA patient perspectives about:

• the symptoms that patients find most significant;
• the impact of their condition on their daily lives;
• what is important to them about current and future treatments.

Since 2012, the FDA has worked with patient groups to hold more than70 PFDD meetings on chronic and rare diseases.

PFDD meetings lead to the publication of a summary report. These are often called the “Voice of the Patient” report. The patient groups hosting the meeting present the report to the FDA after the meeting. The report summarizes what is important to patients when it comes to current and future treatments.

The FDA can use this report to inform the patient perspective for the drug development and evaluation process.