Chapter
ORIGIN OF PRESCRIPTION DRUG USER FEES
PDUFA IMPACT ON FDA REVIEW TIME AND BUDGET
Proposed Legislative Language
Industry-FDA Performance Goals and Procedures for
PDUFA V: The Agreement
APPENDIX A. PROVISIONS IN FFDCA §736 AND §736B
APPENDIX B. PDUFA V AGREEMENT: PERFORMANCE GOALS AND PROCEDURES
Chapter 2:
PRESCRIPTION DRUGS:
FDA HAS MET MOST PERFORMANCE GOALS FOR REVIEWING APPLICATIONS
FDA MET MOST PERFORMANCE GOALS FOR
ORIGINAL NDAS AND BLAS WHILE FDA REVIEW
TIME INCREASED SLIGHTLY
FDA Met Most Performance Goals for Original NDAs and BLAs for FYs 2000 through 2010
Average FDA Review Time Increased Slightly for Original NDAs and BLAs from FY 2000 through FY 2010
Percentage of FDA First-Cycle Approvals Generally Increased from FY 2000 through FY 2010 but Decreased for Priority NDAs and BLAs since FY 2007
FDA MET MOST PERFORMANCE GOALS FOR ORIGINAL EFFICACY SUPPLEMENTS WHILE FDA REVIEW TIME INCREASED SLIGHTLY
FDA Met Most Performance Goals for Original Efficacy Supplements in FYs 2000 through 2010
Average FDA Review Time Generally Increased for Original Efficacy Supplements from FYs 2000 through 2010
Percentage of FDA First-Cycle Approvals Fluctuated for Priority Efficacy Supplements but Generally Increased for Standard Efficacy Supplements from FYs 2000 through 2010
STAKEHOLDERS NOTED ISSUES WITH THE PRESCRIPTION DRUG REVIEW PROCESS AND FDA IS TAKING STEPS THAT MAY ADDRESS MANY OF THOSE ISSUES
Stakeholders Noted Actions or Requirements That They Believe Can Increase Review Times
Stakeholders Cite Insufficient Communication between FDA and Stakeholders throughout the Review Process
Industry Stakeholders Report a Lack of Predictability and Consistency in Reviews
Consumer Advocacy Group Stakeholders Suggest That FDA May Provide Inadequate Assurance of the Safety and Efficacy of Approved Drugs
APPENDIX I. FDA NDA AND BLA REVIEW PERFORMANCE FOR FISCAL YEARS
(FYS) 2000 THROUGH 2011
APPENDIX II: FDA EFFICACY SUPPLEMENT REVIEW PERFORMANCE FOR FISCAL YEARS (FYS) 2000 THROUGH 2011
APPENDIX III. FULL-TIME EQUIVALENT (FTE) FDA STAFF SUPPORTING PRESCRIPTION DRUG USER FEE ACTIVITIES, FYS 2000 THROUGH 2010
FDA Review of Drug Applications
( Government Procedures and Operations )
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