Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

Highlights from the meeting.


Highlights from the meeting.

Picture of Speaker

Previous OHCA Patient Network Annual Meetings.

September 10, 2013: Demystifying FDA- An Exploration in Drug Development

The meeting served as a forum for FDA’s patient stakeholders and the general public, including health professionals, academia, and industry to learn about regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in medical product development and regulatory decision-making.  This meeting provided information and facilitated a discussion about: drug development and regulatory standards, clinical trial design, new regulatory tools for improving premarket drug regulation, and industry-FDA-patient collaboration for innovative drug development.
To view the Federal Register Notice that was published on August 9, 2013


Topic 1: Drug Development and Regulation Overview
  • Novartis and the Drug Development Process
  • Demystifying FDA: A Regulatory Perspective (Presentation not recorded because of technical difficulties)
  • Growing Patient Influence on Drug Development
Topic 2: Innovative Concepts to Encourage Regulatory Flexibility
Introductory to Regulatory Science at the FDA
  • Decisions in Clinical Drug Developmen
  • Drug Development in Rare and Orphan Diseases: Focus on Clinical Trial Design  
Topic 3: Practical Approaches to Patient Input:
  • Breakthrough Therapies   
  • FDASIA Section 1137: Patient Participation in Medical Product Development
  • Patient-Focused Drug Development Initiative
  • Patient-Centered Clinical Trial Decision
  • Benefits of Patient Consultants During the Review Process: A Case Study
Topic 4: Putting the Pieces Together
Panel Discussion:
  • FDA Perspective
  • Patient Advocacy Perspective
  • Industry Perspective
  • FDA-Patient Focused Perspective

Portions of the meeting were not recorded due to technical difficulties. The meeting begins with the last presentation in Topic 1: Growing Patient Influence on Drug Development. The question and answer portion of the meeting were deleted due to audio difficulties.  To view 2013 Patient Meeting or 2012 Patient Meeting