• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

For Industry

  • Print
  • Share
  • E-mail

APPENDIX B: SPONSOR AND FDA FOCUS GROUP FINDINGS: Independent Evaluation of FDA's First Cycle Review Performance – Final Report

Table of Contents

APPENDIX A: GRMPS IMPLEMENTATION STATUS

In March 2006, two industry focus groups were convened that represented 19 companies with recent product submissions. The objective of the industry focus group was to capture industry reaction to GRMPs and factors that contribute to or detract from first-cycle approval.  The focus group participants spanned the pharmaceutical and biotechnology sectors with 47% representing large pharmaceutical companies, 21% representing large biotechnology, 16% representing small biotechnology and 16% representing small to medium Pharma. [23]  The average self-reported regulatory experience of the participants was 14 years and in total spanned all CBER/CDER product divisions.  Following the sponsor focus groups, two FDA focus groups were held to collect comparative perspectives from discipline reviewers, Medical team leads, chief Regulatory Project Managers, Regulatory Project Managers, branch chiefs and policy analysts.

Industry participants indicated they found varying levels of GRMPs compliance across Divisions.  Few sponsors had made any internal process changes in response to the GRMPs issuance and even fewer had provided input to the draft GRMPs.  The industry participants reported the GRMPs guidance and principles were valued. Further, the industry participants anticipated the GRMPs would enhance standardization of review communication practices across Divisions.  Finally, industry participants felt it was too soon to assess the impact of GRMPs as the rollout is underway but some had used the guidance for internal education of management regarding FDA review practices.

Sponsors agreed that an effective communication plan with FDA is important and would help establish expectations, promote consistency across Divisions, and allow for needed review updates without adversely impacting FDA reviewers workloads (Exhibit 54).

Exhibit 54.  Review Communication Practices Preferred by Industry and FDA Focus Group Participants

Chart of Review Communication Practices Preferred by Industry and FDA Focus Group Participants

Industry participants believed review team consistency contributed to a good review and that Regulatory Project Manager experience was critical; they believed RPM changes (e.g., staff turnover) were detrimental to the review.  When considering the filing and planning and review phases, sponsors saw value in the Application Orientation meeting [24] but believed the 74-Day letter was useful only if it contains major review issues.  Industry participants believed their response time to identified issues took into consideration the severity of the issues and sometime was impacted by the need for FDA staff to clarify issues or needed actions (Exhibit 55).

Exhibit 55. Industry and FDA Focus Group Feedback on GRMPs Filing and Planning and Review Activities

Chart of Industry and FDA Focus Group Feedback on GRMPs Filing and Planning and Review Activities

When considering the Advisory Committee, action and post-action phases, both FDA and sponsors agreed Advisory Committee meetings are resource intensive and especially challenging for the six-month, Priority reviews.

 56. Industry and FDA Focus Group Feedback on GRMPs Advisory Committee, Action and Post-Action Phases

Chart of Industry and FDA Focus Group Feedback on GRMPs Advisory Committee, Action and Post-Action Phases


APPENDIX C: STUDY HYPOTHESES