QbR: 2014 Vision by Director of ONDQA FDA


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QbR: A Vision by Director of ONDQA FDA

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QbR: 2014 Vision by Director of ONDQA FDA

  1. 1. Question-Based Review- A Vision Ramesh Sood, Ph.D. Division Director (Acting) Office of New Drug Quality Assessment 24-Jan-2014 1
  2. 2. Outline • • • • • • What is QbR History Potential benefits Process Feedback Next steps 2
  3. 3. What is QbR • Question-based Review (QbR) is a general framework for a science and risk-based assessment of product quality • Question-based review incorporates important scientific and regulatory review questions • ANDA/NDA applicants answer these questions in module 2 • The quality reviewers evaluate the responses and body of data in module 3 supporting applicant’s answers • The questions apply to both new drug applications and generic drug products 3
  4. 4. What is QbR • The questions are high level questions that address the critical development aspects, product performance aspects and manufacturing controls across dosage forms – – – – Related to product design Product performance Risk to product performance Control strategy • A single set of questions that apply to both new drug applications and generic drug products • A checklist to capture noteworthy aspects of the application 4
  5. 5. QbR Elements • No change to module 3 • The questions are formatted based on ICH M4 QOS format resulting in minimal change for applicants generating multi-region submissions • Questions are located in Module 2, QOS • A checklist to include noteworthy features of the application (e.g., design space, formulation flexibility etc.) • A companion document with points to consider while responding to each question on content – 5
  6. 6. History • Currently being used by generic industry to submit drug product information in ANDA submissions • QbR initiative started in year 2005 in Office of Generic Drugs • QbR fully implemented for generic drugs in year 2007 • Exploration of QbR for new drugs and for drug substances initiated in year 2013 within FDA 6
  7. 7. Benefits to Reviewers • QbR approach streamlines the review Guide to reviewers for consistent and comprehensive quality evaluation Determination of level of risk associated with design, performance and manufacture of the product Puts on paper many of the internal questions that a reviewer has while reviewing the submission 7
  8. 8. Benefits to Reviewers (contd.) Reviewers spend time only documenting their critical scientific assessment with rationale Allows reviewers to conduct risk-based review Little or no time spent on summarizing the application Provides consistency among the submissions Leads to more focused and faster review • OGD experienced improvement in the quality of submissions 8
  9. 9. Benefits to Applicants • Provides clear indication to the applicant about the reviewer’s expectations and concerns – Provides transparency about the logic invoked by reviewers – A window to the reviewer’s concerns • Provides opportunity to address critical questions about the product’s design, performance, manufacturing controls and risk of product failure both at the performance and patient usability perspective • Expected to lead to fewer questions from the reviewers during the review cycle 9
  10. 10. Process • Used the current QbR questions from OGD as the starting point • NDA submissions were reviewed by OPS reviewers with respect to the current OGD questions • Based on the gap analysis, a revised set of questions was generated through collaboration between OGD and ONDQA reviewers • Additional NDAs are being reviewed based on the new set of questions 10
  11. 11. Initial Reviewer Feedback • Leads to more focused and faster review • Reviewers spend time only documenting critical scientific assessment with rationale • QbR questions shifted emphasis of assessment to areas that were most likely to affect the quality as it relates to product performance • Standardized review enhances the quality of the CMC evaluation 11
  12. 12. Future Steps • Gain more QbR implementation experience among CDER reviewers • Have a dialog with stakeholders (e.g., PhRMA) and other regulatory agencies • Refine questions based on reviewer and industry feedback • Seek industry volunteers for QbR submissions, potentially through a pilot program 12
  13. 13. Acknowledgements • Dr. Lawrence Yu, Acting Director, OPS • Dr. Christine Moore, Acting Director, ONDQA • QbR working group at FDA • All of you for your attention 13
  14. 14. Questions? NewDrugCMC@fda.hhs.gov 14
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