A Chat With Janet Woodcock: FDA Exec Discusses Development Obstacles, And FDA’s Efforts To Overcome Them

06 Feb 2006
Analysis

Andrew Kasper a.kasper@elsevier.com

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DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter

Amgen Aranesp, Vectibix Setbacks Illustrate Risks Of Real World Trials

Amgen's failed Anemia of Cancer trial of Aranesp and Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) trial of Vectibix may illustrate the potential pitfalls facing sponsors that conduct "real world" trials of their products

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A Chat With Janet Woodcock: FDA Exec Discusses Development Obstacles, And FDA’s Efforts To Overcome Them

Analysis

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Advisory Committees In 2006: FDA Advisory Cmte. Reviews To Focus More On Lifecycle Of Drugs

NME Slowdown Shows Market Pressure On Me-Toos, Not FDA Caution – Lutter

Amgen Aranesp, Vectibix Setbacks Illustrate Risks Of Real World Trials

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A Chat With Janet Woodcock: FDA Exec Discusses Development Obstacles, And FDA’s Efforts To Overcome Them

Analysis

You may also be interested in...

Advisory Committees In 2006: FDA Advisory Cmte. Reviews To Focus More On Lifecycle Of Drugs

NME Slowdown Shows Market Pressure On Me-Toos, Not FDA Caution – Lutter

Amgen Aranesp, Vectibix Setbacks Illustrate Risks Of Real World Trials

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