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The US Drug Approval Trends and Yearbook

Posted on: 27 Jun 08
The US Drug Approval Trends and Yearbook

Summary

Finally a comprehensive source for the very latest performance metrics and trend analysis on every key aspect of the new drug approval processThe US Drug Approval Trends and Yearbook 2006/2007!

In this first-of-its-kind compendium, we examine 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 2006/2007 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.

For a complete index of this report click here:



Report Index:

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 Actions

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 Drugs

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

Division 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



Pricing:



Hard Copy : EUR 316



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2] Order by fax: Print an Order form from and Fax to +353 1 4100 980



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Rachel Thompson

Last updated on: 27/08/2010 11:40:18

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