The Future of Drug Safety Promoting and Protecting the Health of the Public (2007) / Chapter Skim
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Appendix C PDUFA Performance Goals—All Years
Appendix C PDUFA Performance Goals—All Years
Pages 221-254
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Appendix C PDUFA Performance Goals -- All Years The following list presents by fiscal year the performance measures set forth in the letters referenced in Section 102(3)
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THE FUTURE OF DRUG SAFETY TABLE C-1 Continued Timing of Measurement Datea Interim Goals by Fiscal Year Measurement 3. Review and act upon 55 percent of manufacturing 6 months after Mar.
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APPENDIX C TABLE C-1 Continued Timing of Measurement Datea Interim Goals by Fiscal Year Measurement 2. Review and act upon 80 percent of efficacy 12 months after Sept.
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, as agreed to under the reauthorization of the prescription drug user fee program in the "Food and Drug Administration Modernization Act of 1997," are summarized as follows: I FIVE-YEAR REVIEW PERFORMANCE GOALS Fiscal year 1998 1.
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APPENDIX C 4. Review and act on 90 percent of priority efficacy supplements filed dur ing fiscal year 1999 within 6 months of receipt.
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THE FUTURE OF DRUG SAFETY 4. Review and act on 90 percent of priority efficacy supplements filed dur ing fiscal year 2001 within 6 months of receipt.
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APPENDIX C TABLE C-3 Manufacturing Supplements MANUFACTURING SUPPLEMENTS MANUFACTURING THAT DO NOT REQUIRE PRIOR SUPPLEMENTS THAT SUBMISSION APPROVAL ("CHANGES BEING DO REQUIRE PRIOR COHORT EFFECTED" OR "30-DAY SUPPLEMENTS APPROVAL FY 98 90% IN 6 MO 90% IN 6 MO FY 99 90% IN 6 MO 30% IN 4 MO 90% IN 6 MO FY 00 90% IN 6 MO 50% IN 4 MO 90% IN 6 MO FY 01 90% IN 6 MO 70% IN 4 MO 90% IN 6 MO FY 02 90% IN 6 MO 90% IN 4 MO TABLE C-4 Resubmission of Original NDAs/BLAs/PLAs SUBMISSION COHORT CLASS 1 CLASS 2 FY 98 30% IN 2 MO 90% IN 6 MO 90% IN 6 MO FY 99 50% IN 2 MO 90% IN 6 MO 90% IN 4 MO FY 00 70% IN 2 MO 90% IN 6 MO 90% IN 4 MO FY 01 90% IN 2 MO 90% IN 6 MO FY 02 90% IN 2 MO 90% IN 6 MO II.
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THE FUTURE OF DRUG SAFETY face, teleconference, or videoconference) CBER and CDER should notify the requester in writing (letter or fax)
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APPENDIX C 1. A written request (letter or fax)
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0 THE FUTURE OF DRUG SAFETY calendar days of the Center's receipt of the written appeal starting in FY99; 80 percent in FY00; and 90 percent in subsequent fiscal years.
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3. Protocols that qualify for this program include: carcinogenicity protocols, stability protocols, and Phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim.
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THE FUTURE OF DRUG SAFETY VII. ELECTRONIC APPLICATIONS AND SUBMISSIONS The Agency shall develop and update its information management infrastructure to allow, by fiscal year 2002, the paperless receipt and processing of INDs and human drug applications as defined in PDUFA, and related submissions.
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APPENDIX C 5. Commitments to perform Phase 4 studies, including proposals for such studies 6.
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, as agreed to under the reauthorization of the prescription drug user fee program are summarized as follows: I
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APPENDIX C Fiscal Year 00: 1. Review and act on 90 percent of Class 1 resubmitted efficacy supplements filed during fiscal year 2004 within 4 months of receipt and review and act on 50 percent within 2 months of receipt.
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THE FUTURE OF DRUG SAFETY TABLE C-7 Resubmitted Efficacy Supplements SUBMISSION COHORT CLASS 1 CLASS 2 FY 2003 90% IN 6 MO 90% IN 6 MO 30% IN 2 MO FY 2004 90% IN 4 MO 90% IN 6 MO 50% IN 2 MO FY 2005 90% IN 4 MO 90% IN 6 MO 70% IN 2 MO FY 2006 90% IN 4 MO 90% IN 6 MO 80% IN 2 MO FY 2007 90% IN 2 MO 90% IN 6 MO TABLE C-8 Manufacturing Supplements MANUFACTURING SUPPLEMENTS NO PRIOR APPROVAL ("CHANGES BEING MANUFACTURING SUBMISSION EFFECTED" OR "30-DAY SUPPLEMENTS THAT DO COHORT SUPPLEMENTS")
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APPENDIX C B Scheduling Meetings 1.
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THE FUTURE OF DRUG SAFETY e. A listing of requested participants/disciplines representative(s)
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3. Protocols that qualify for this program include: carcinogenicity protocols, stability protocols, and Phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim.
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0 THE FUTURE OF DRUG SAFETY the developmental context in which the protocol is being reviewed and the questions being answered.)
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APPENDIX C 3. If following an initial review FDA finds a "reviewable unit" to be substantially complete for review (i.e., after a "filing review" similar to that performed on an NDA/BLA)
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THE FUTURE OF DRUG SAFETY submission for 50 percent of "reviewable units" submitted in FY05; c. Discipline review team review of a "reviewable unit" for a Fast Track drug or biologic will be completed and a DRL issued within 6 months of the date of the submission for 70 percent "reviewable units" submitted in FY06, and d.
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APPENDIX C FDA Modernization Act (21 U.S.C.
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PRE- AND PERI-NDA/BLA RISK MANAGEMENT PLAN ACTIVITIES A Submission and Review of pre-NDA/BLA meeting packages: A pre NDA/BLA meeting package may include a summary of relevant safety information and industry questions/discussion points regarding pro posed risk management plans and discussion of the need for any post approval risk management studies.
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(ICH Guidance E2C, Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs) and addressed during the peri-approval period through discussions between the ap plicant and FDA.
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INDEPENDENT CONSULTANTS FOR BIOTECHNOLOGY CLINICAL TRIAL PROTOCOLS A Engagement of Expert Consultant: During the development period for a biotechnology product, a sponsor may request that FDA en gage an independent expert consultant, selected by FDA, to partici pate in the Agency's review of the protocol for the clinical studies that are expected to serve as the primary basis for a claim.
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APPENDIX C F Evaluation: During FY 2006, FDA will conduct a study to evaluate the costs and benefits of this program for both sponsors and the Agency.
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THE FUTURE OF DRUG SAFETY C Training: FDA will develop and implement a program for training all review personnel, including current employees as well as future new hires, on the good review management principles.
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APPENDIX C five years of PDUFA III funds for initiatives targeted to improve the drug review process.
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0 THE FUTURE OF DRUG SAFETY of the process, a re-map of the process indicating where efficien cies can be gained, activity-based project accounting, optimal use of review tools, and a suggested path for implementing the recommendations.
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APPENDIX C D FDA will deliver a single point of entry for the receipt and processing of all electronic submissions in a highly secure environment.
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THE FUTURE OF DRUG SAFETY their regulations and processes to provide for the issuance of either an "approval" (AP) or a "complete response" (CR)
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APPENDIX C 10. Other specific items may be added later as the Agency gains ex perience with the scheme and will be communicated via guidance documents to industry.
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