Building an Effective Regulatory Relationship with the FDA

Table of Contents

EXECUTIVE SUMMARY

• Project Background
• Research Methodology
• Key Findings
  • Figure 1 - Top Methods for Working with the FDA
• Benchmark Class
  • Figure 2 - Best Practices LLC Benchmark Class
• Report Structure and Organization

STRUCTURE AND ROCKVILLE SATELLITE OFFICE

• Overview
• Organizational Structure
  • Figure 1.1 - Organizational oversight of FDA Function
  • Figure 1.2 - Companies choose to mirror FDA structure
  • Figure 1.3 - Align your staff with their FDA peers
• Centralization of Function
  • Figure 1.4 - Organizational Structure for FDA Interaction
  • Figure 1.5 - Regulatory oversees corporate FDA interactions
  • Figure 1.6 - More utilization of Rockville office possible
  • Figure 1.7 - FDA focus vital component of Rockville offices
  • Figure 1.8 - More emphasis placed on FDA liaison role
  • Figure 1.9 - Key competencies needed in Rockville

BUILDING EFFECTIVE RELATIONSHIPS

• Overview
• Formal Relationships
  • Figure 2.1 - Engagement strategy for FDA staff
  • Figure 2.2 - FDA reviewers make optimal partners
• Informal Relationships
• Emails vs. Phone Calls
  • Figure 2.3 - Emails and phone best ways to contact FDA
  • Figure 2.4 - Email used to build informal FDA relationships
• Attending Conferences

WORKING WITH AND UNDERSTANDING THE FDA AND WASHINGTON ECOSYSTEM

• Overview
• Working on Relationships
• The Role of Reputation
  • Figure 3.1 - Pharmas most admired for FDA navigation skills
  • Figure 3.2 - Biotechs most admired for FDA navigation skills
• The Washington Ecosystem

SKILLS, CAPABILITIES, AND COMPETENCIES FOR SUCCESS

• Overview
• A Dynamic Profession
  • Figure 4.1 - RA Profession - Integral to Healthcare Product Lifecycle
• Skill Sets
  • Figure 4.2 - A matrix of characteristics can help in FDA work
  • Figure 4.3 - Regulatory knowledge is most valued trait
  • Figure 4.4 - Legal/Regulatory background can help
  • Figure 4.5 - Regulatory or clinical backgrounds preferred
• Science versus Regulatory Experience
  • Figure 4.6 - Balancing backgrounds and skill sets
• FDA Experience
  • Figure 4.7 - Hiring the right kind of FDA staff
  • Figure 4.8 - Companies have few staff with FDA experience
• Performance Measurement
  • Figure 4.9 - Regulatory uses multiple performance metrics

PLANNING AND PREPARATION FOR THE NDA

• Overview
• Starting with the NDA
  • Figure 5.1 - The high quality NDA support safety
• Who speaks, Leads
• Minutes
• Working with the Project Manager
  • Figure 5.2 - Gatekeeper model favored in FDA relationships
• Preparing for NDA Meetings
  • Figure 5.3 - Key roles during NDA process
  • Figure 5.4 - Companies divided about using outside expert
• Meeting Rehearsals
  • Figure 5.5 - Many ways to help prepare NDA presentations
  • Figure 5.6 - Mock reviews core approaches for FDA preparation
• Negotiating for a Win-Win with Labeling
  • Figure 5.7 - The draft label sets the tone

SAFETY AND RISK MANAGEMENT

• Overview
• Refocusing on Safety
  • Figure 6.1 - FDA continues to emphasize safety
  • Figure 6.2 - Safety-Based withdrawals
• Risk Evaluation and Mitigation Strategies
• Changing the Safety Landscape