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The US Drug Approval Trends and Yearbook 2008/2009

Barnett Educational Services
July 1, 2008
200 Pages - SKU: BNT2406785

Abstract Table of Contents Related Reports

Countries covered: United States

Finally a comprehensive source for the very latest performance metrics and trend analysis on every key aspect of the new drug approval process--The US Drug Approval Trends and Yearbook 2008/2009!

Building on last year's widely read edition, the new 2008/2009 edition examines hundreds of key trends and metrics to provide industry with all-new benchmarks and metrics on which to assess their own performance, to plan their own R&D projects, and to assess the various drug approval options and strategies available to them.

The US Drug Approval Trends and Yearbook 2008/2009 provides an unprecedented number of in-depth analyses and benchmarks, including the following:

NDA and NME first-cycle success rates, review outcomes, and trends

Complete review and approval profiles for each NME and NDA, including cycles to approval, review times, and review outcomes

Analysis of drug review times, review cycle outcomes and success rates by therapeutic category and standard vs. priority classification

NDA and NME cycles to approval and review times through mid-2006

The impact of priority review, fast track, accelerated approval, orphan drug status and related programs on review times and review outcomes

Review outcomes, review times, and success rates for other key new drug submissions, including NDA resubmissions, efficacy supplements, and manufacturing supplements

Based on data compiled through internal studies, Freedom of Information requests to the FDA, and other public and private sources, our proprietary analyses will provide you with unique insights, benchmarks, and performance metrics in areas critical to the success of your R&D projects. We guarantee it!

Please note: The delivery of this report requires Adobe 6 or higher, and the ability to install right management plugin for Adobe.

Introduction
U.S. New Drug Approval Output: The Top Line Metrics in Brief
NDA Approval Output
FDA NME Approvals, 1990-2006
NME Approvals in the U.S.: 1990-2006
New Drug Review Times: The Top Line Metrics in Brief
Mean and Median NME Review Time Data
Division-by-Division Average NME Review Times
Division of Metabolism and Endocrinology Products
Division of Anti-Infective and Ophthalmologic Products
Division of Oncologic Drug Products
Division of Antiviral Products
Notes on Other Divisions
Median NDA Review Time Statistics
A Comprehensive Analysis of First-Cycle Review Outcomes for New Drugs
CDER-Wide Statistics for First-Cycle NDA Review Outcomes:
FY2004 and FY2005 NDA Cohorts
FY2004 Cohort Performance and a Look Ahead to FY2005 Cohort
A Look at Other First-Cycle Review Outcomes
Approvable Action
Not-Approvable Actions .
First-Cycle Review Outcomes for Priority/Standard NDAs
First-Cycle Approval Trends
First-Cycle Approval Rates for NMEs
Other First-Cycle Review Outcomes for Priority and Standard NDAs
Division-by-Division First-Cycle Review Tendencies
Division of Oncologic Drug Products
Division of Gastroenterology Products
Division of Metabolism and Endocrinology Products
Division of Neurology Products and Division of Psychiatry Products
Division of Reproductive and Urologic Products
Division of Special Pathogens and Transplant Products
Division of Cardiovascular and Renal Products
Division of Dermatologic and Dental Products
Division of Pulmonary and Allergy Products
Division of Anti-Infective and Ophthalmologic Products.
Division of Anesthesia, Analgesia, and Rheumatology Products.
Division of Medical Imaging and Hematology Products
An Analysis of Review Cycles to Approve for New Drugs
Cycles to Approval Analysis for NMEs .
Examining the Review Cycles for the NMEs Cleared in 2005 and 2006
Examining the Review Cycles for the NDAs Cleared in Recent Fiscal Years, FY2000-FY2005
Performance Metrics Beyond the First Review Cycle: An Assessment of NDA Resubmissions
CDER-Wide Performance Metrics for NDA Resubmissions
Class 1 Resubmission Review Outcomes
Class 2 Resubmission Review Outcomes
NDA Resubmission Review Time Performance
Division-by-Division Resubmission Statistics
An Assessment of Priority vs. Standard Review Ratings: Their Impact on Drug Reviews and Approvals
Priority vs. Standard Drug
Standard vs. Priority Drug Reviews: Does It Really Matter?
Standard vs. Priority NME Review Times
Standard vs. Priority NDA Review Times
Priority Drug Review Designations: How Many and What Drugs Are Getting Them?
Priority Designations Among NMEs
Mean Clinical Phase and Approval Times for Priority and Standard NCEs Approved 1984-2004
Priority Designations Among All NDAs
Priority Designations: Which Drugs Are Receiving Them?
Priority Drug Review Designations: Who Is Granting Them?
Division of Oncologic Products
Division of Gastroenterology Products
Division of Metabolic and Endocrine Products
Division of Neurology and Division of Psychiatry Products
Division of Reproduction and Urologic Products.
Division of Special Pathogens and Transplant Products
ivDivision of Cardiovascular and Renal Products
Division of Antiviral Products
Division of Medical Imaging and Hematology Products
Division of Dermatologic and Dental Products
Division of Pulmonary Products
Division of Anti-Infective and Ophthamologic Products
Division of Anesthesia, Analgesia and Rheumatology Products
The FDA’s Fast Track Program and the Drug Approval Process: The Metrics
Fast Track Status: Is It a Link to Priority Status?
Is Fast Track Really a “Fast Track”?
Challenges in Fast Track Development Programs
Industry Success Rates in Obtaining Fast Track Status
Fast Track Designations: What Product Types are Receiving Them?
A Look at Fast Track Product Approvals
The FDA’s Accelerated Drug Approval Program (Subpart H) and the New Drug Approval Process: The Metrics
FDA Accelerated Approval Program Comes Under Fire.
The Appeal of Accelerated Approval
Subpart H Drugs: What Are They?
The Orphan Drug Program and Its Effect on the Drug Approval Process
Orphan Drugs and Their Impact on New Drug Approvals
The Approval Time Advantage for Orphan Drug Products
An Assessment of Regulatory Metrics for NDA Effectiveness Supplements
CDER-wide Review Outcomes for Efficacy Supplements
Review Time Metrics for Efficacy Supplements
Division-by-Division Review Statistics
Division of Cardiovascular and Renal Products
Division of Neurology Products
Division of Psychiatry Products
Division of Metabolism and Endocrinology Products
Division of Anesthesia, Analgesia, and Rheumatology Products
Division of Drug Oncology Products
Division of Medical Imaging and Hematology Products
Division of Gastroenterology Products
Division of Dermatology and Dental Products
Division of Pulmonary and Allergic Products
Division of Reproductive and Urologic Products
Division of Antiviral Products
Division of Anti-Infective and Ophthalmic Products
Division of Special Pathogen and Transplant Products
An Assessment of Review Metrics for Manufacturing Supplements
Appendix
Appendix A-Detailed Summary of Booz Allen Hamilton Report on First-Cycle Review Performance
Appendix B-A Look at the 50 Fastest Drug Reviews, 1963-2005
Appendix C-Postmarketing Study Commitment Trends for New Drugs: An Analysis of NMEs Approved 2001-2005
Appendix D-Gaining Access to the NDA Review Process: A Brief Look at CDER’s Refuse-to-File Rates

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