CDER Forum for International Drug Regulatory Authoritie Good

CDER Forum for International Drug Regulatory Authoritie Good Review Practices (GRPs) in the United States CDER Forum for International Drug Regulatory Authorities October 1, 2007 Howard D. Chazin, MD MBA FDA CDER Office of New Drugs Objectives For This Lecture • Describe the philosophies underlying Good Review Practices as developed by CDER/OND for their drug product review staff. • Recognize examples of CDER GRP documents including review templates, MAPPs and Guidances for Review Staff and Industry. October 1, 2007 – Howard D. Chazin, MD MBA 1 CDER Forum for International Drug Regulatory Authoritie Philosophy • Developing Good Review Practices is an attempt to identify, collect, enhance, implement, and adopt internal best product review practices as documented and standardized approaches that can be shared among all review divisions. GRPs are developed: • Based on reviewer experiences • As a response to changing regulatory environments (e.g., the Prescription Drug User Fee Act) • To formulate an overall quality systems approach to product review October 1, 2007 – Howard D. Chazin, MD MBA 2 CDER Forum for International Drug Regulatory Authoritie CDER Quality Systems Approach Improve it Say what you do Prove it Do what you say Quality Systems Approach to GRPs Evaluate or reevaluate Develop GRP Mentor and Train Staff Implement October 1, 2007 – Howard D. Chazin, MD MBA 3 CDER Forum for International Drug Regulatory Authoritie CDERs GRPs are… • Documented best practices that discuss any aspect related to the process, format, content, and/or management of a product review. • Developed over time as superior practices based on CDER’s collective experience. • Intended to provide consistency to the overall review process of new drugs. CDERs GRP Fundamental Values • • • • • Quality Efficiency Clarity Transparency Consistency October 1, 2007 – Howard D. Chazin, MD MBA 4 CDER Forum for International Drug Regulatory Authoritie Quality • Consistent implementation of GRPs by review staff will enhance the quality of reviews, the review process, and the resultant regulatory action. Efficiency • GRPs will improve the efficiency of the review process through standardization. October 1, 2007 – Howard D. Chazin, MD MBA 5 CDER Forum for International Drug Regulatory Authoritie Clarity • GRPs support clarity throughout the review process, including critical review and decision making prior to a regulatory action. Transparency • Developing and documenting GRPs ensures that CDERs review processes are readily available for review by both sponsors and the public. October 1, 2007 – Howard D. Chazin, MD MBA 6 CDER Forum for International Drug Regulatory Authoritie Consistency • By offering a consistent approach and only deviating from it when appropriate, GRPs help reviewers achieve consistency with their reviews and standardize review processes across divisions. Reviews before GRPs-Problems • Format and content of product reviews at the discretion of each individual reviewer without a standard outline or table of contents. • Every review posted on the web looked different and it was difficult to find particular sections of the review. • Sometimes reviewers inadvertently omitted critical information and analyses. October 1, 2007 – Howard D. Chazin, MD MBA 7 CDER Forum for International Drug Regulatory Authoritie Solution- Standard review templates and template MAPPs – Provide a framework and structure for writing a review – Act as a checklist to insure completeness – Give a consistent location for information • Section 6 is the Efficacy Review • Section 7 is the Safety Review – Train reviewers in how to perform their reviews Reviews after GRPs-Improved • Reviews contained predictable headings and were consistently organized. • Reviews contained critical analyses previously omitted. • Review staff learned what was expected for their reviews. October 1, 2007 – Howard D. Chazin, MD MBA 8 CDER Forum for International Drug Regulatory Authoritie CDER GRP Web Site • All CDER Good Review Practices are now located on an FDA/CDER website. http://www.fda.gov/cder/other/grp.html October 1, 2007 – Howard D. Chazin, MD MBA 9 CDER Forum for International Drug Regulatory Authoritie Good Review Practices (MAPP) • Instructs review staff on what GRPs are. • Provides general policies, roles and responsibilities for all future GRPs October 1, 2007 – Howard D. Chazin, MD MBA 10 CDER Forum for International Drug Regulatory Authoritie Good Review Management Principles and Practices for PDUFA Products (Guidance) • Gives an ideal timeline for a first cycle NDA/BLA review • Reflects expectations both FDA and sponsors as negotiated through PDUFA Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Guidance) • Very detailed instructions on how reviewers should perform a safety review • Offers philosophy of how to prioritize safety issues • Concentrates on evaluating pooled safety data from the Integrated Summary of Safety (ISS), an FDA specific regulatory requirement. October 1, 2007 – Howard D. Chazin, MD MBA 11 CDER Forum for International Drug Regulatory Authoritie Clinical Review Template (MAPP) • An annotated standard outline for preparing and documenting the primary clinical review of original NDA/BLA applications, NDA/BLA amendments in response to action letters and efficacy supplements. • Currently under review for revisions. Labeling for Human Prescription Drugs-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (Guidance) • Reflects final rule regulations for content and format of labeling for drugs. • Focuses on the Indications and Usage section of Highlights October 1, 2007 – Howard D. Chazin, MD MBA 12 CDER Forum for International Drug Regulatory Authoritie In Summary, GRPs… • Provide a more consistent approach to the review and approval of new products • Specify our process, format and content of a review • Standardize reviews and review management • Train staff • Inform industry of our internal review best practices howard.chazin@fda.hhs.gov October 1, 2007 – Howard D. Chazin, MD MBA 13