If this box remains here for more than 30 seconds, click this link to try again.
Home » Products & Services » Benchmarking Reports » Quality Compliance & Regulatory
Download FREE Excerpt
8 Info Graphics
27 Data Graphics
300 Metrics
50 Narratives
Single User: Authorizes use by the person who places the order or for whom the order was placed.
Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.
Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.
Buy Now
Applicant companies that frequently gain approval and first approvals – and avoid delays or, worse, the nebulous and costly “complete response” letter – brandish not only good science but also cultivate and sustain strong working relationships with the FDA and its staff. The topic of informal working relationships between pharmaceutical representatives and the FDA is a sensitive one for all parties. Regulatory officials in pharma hold distinct views on what characterize effective communication strategies and tactics with the agency. This report delivers benchmarks and insights that identify approaches for understanding and effectively interacting with the FDA. The research is based on detailed survey data from Regulatory Affairs executives and managers from 15 top pharmaceutical companies. The report includes insights gleaned from interviews with 13 Regulatory executives who boast extensive experience with NDAs and the FDA.
Key Findings Organizational Structure: Four-fifths of all companies in this research are either a U.S.-based company that places oversight of FDA interactions within headquarters or are companies not based in the U.S. that place such oversight with their U.S. subsidiary offices. No benchmarked companies use a decentralized structure as this would hinder oversight of corporate FDA interactions. Nearly two-thirds of the benchmark partners are highly centralized in how they oversee FDA interactions. Hiring for Regulatory Affairs: Most Regulatory staffs have few former FDA employees, let alone former top-level FDA employees. Some research participants said that only former agency officials who were highly placed in the administration will benefit organizations when it comes to working with the FDA, citing a tendency in lower-level former FDA employees toward bureaucracy. Managing an NDA: Avoid level-skipping to accelerate a decision. Level-skipping can cause longer-term resentment, distrust and harm to your NDA within the FDA. In addition, eighty percent of benchmark partners see the designation of a single point of contact for FDA communications during the NDA process as the most effective approach to creating and maintaining successful interactions with the agency.
PROJECT BACKGROUND 6
RESEARCH METHODOLOGY 6
KEY FINDINGS 7
THE BENCHMARK CLASS 11
REPORT STRUCTURE AND ORGANIZATION 11
Structure and Rockville Satellite Office Overview 14
ORGANIZATIONAL STRUCTURE 15
CENTRALIZATION OF FUNCTION 17
ROLE OF ROCKVILLE SATELLITE OFFICE 20
Building Effective Relationships 26
OVERVIEW 26
FORMAL RELATIONSHIPS 27
INFORMAL RELATIONSHIPS 31
EMAILS VS. PHONE CALLS 33
ATTENDING CONFERENCES 34
Working with and Understanding the FDA and Washington Ecosystem 37
OVERVIEW 37
WORKING ON RELATIONSHIPS 38
THE ROLE OF REPUTATION 40
THE WASHINGTON ECOSYSTEM 42
Skills, Capabilities and Competencies for Success 46
OVERVIEW 46
A DYNAMIC PROFESSION 47
SKILL SETS 47
SCIENCE VERSUS REGULATORY EXPERIENCE 51
FDA EXPERIENCE 54
PERFORMANCE MEASUREMENT 55
Planning and Preparation for the NDA 58
OVERVIEW 58
STARTING WITH THE NDA 59
WHO SPEAKS, LEADS 60
MINUTES 61
WORKING WITH THE PROJECT MANAGER 63
PREPARING FOR NDA MEETINGS 64
MEETING REHEARSALS 66
NEGOTIATING FOR A WIN-WIN WITH LABELING 70
Safety and Risk Management 70
OVERVIEW 73
REFOCUSING ON SAFETY 74
RISK EVALUATION AND MITIGATION STRATEGIES 77
CHANGING SAFETY LANDSCAPE 78 List of Charts & Exhibits TABLES AND FIGURES
Figure 1: Top Methods for Working with the FDA 7
Figure 2: Best Practices LLC benchmark Class 11
Figure 1.1: Organizational oversight of FDA Function 15
Figure 1.2: Companies choose to mirror FDA structure 16
Figure 1.3: Align your staff with their FDA peers 17
Figure 1.4: Organizational Structure for FDA Interactions 18
Figure 1.5: Regulatory oversees corporate FDA interactions 19
Figure 1.6: More utilization of Rockville office possible 21
Figure 1.7: FDA focus Vital component of Rockville Offices 22
Figure 1.8: More Emphasis places on FDA Liaison Role 22
Figure 1.9: Key competencies needed in rockville 24
Figure 2.1: Engagement Strategy for FDA Staff 27
Figure 2.2: FDA Reviewers make Optimal partners 28
Figure 2.3: Emails and Phone best ways to contact FDA 33
Figure 2.4: Email Used to build informal FDA relationships 34
Figure 3.1: Pharmas most admired for FDA navigation skills 41
Figure 3.2: Biotechs Most Admired for FDA Navigation Skills 42
Figure 4.1: RA Profession - Integral to Healthcare Product Lifecycle 47
Figure 4.2: A matrix of characteristics can help in FDA work 48
Figure 4.3: Regulatory Knowledge is most valued trait 49
Figure 4.4: Legal/Regulatory background can help 49
Figure 4.5: Regulatory or clinical Backgrounds Preferred 50
Figure 4.6: Balancing Backgrounds & skill sets 53
Figure 4.7: Hiring the right kind of FDA staff 54
Figure 4.8: Companies have few staff with FDA experience 55
Figure 4.9: Regulatory uses Multiple Performances Metrics 56
Figure 5.1: The high quality NDA support Safety 59
Figure 5.2: Gatekeeper Model Favored in FDA relationships 63
Figure 5.3: Key Roles During NDA Process 65
Figure 5.4: Companies divided about using outside expert 66
Figure 5.5: Many ways to help prepare NDA presentations 68
Figure 5.6: Mock reviews core approaches for FDA prepration 68
Figure 5.7: The draft label sets the tone 71
Figure 6.1: FDA continues to emphasize safety 74
Figure 6.2: Safety-Based Withdrawals 75