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Applied Clinical Trials-08-01-2005
Applied Clinical Trials
Keeping Approvals on Track
August 01, 2005
Feature Article
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Registries could strengthen the postapproval safety net-critical in the current cautious environment.
Connecting Bench to Bedside
August 01, 2005
Special Section: The Critical Path Initiative-Part One
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The Food and Drug Administration's (FDA) Critical Path Initiative and subsequent guidance documents have sparked the revitalization of the life sciences industry.
EU Guidance on Guidance
August 01, 2005
View from Brussels
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The EMEA's guidance is a roadmap for understanding current and future guidelines.
Pointing Us in the Right Direction
August 01, 2005
Special Section: The Critical Path Initiative-Part One
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It's hard to argue with the basic premise of the FDA's Critical Path Initiative-to help the flow of medical products through the development pipeline.
The Critical Path Initiative: A Good Idea at a Bad Time?
August 01, 2005
Special Section: The Critical Path Initiative-Part One
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FDA's Critical Path Initiative is an excellent idea, but is the time right?
Cardiac Safety Speaks to the Heart of the Critical Path Initiative
August 01, 2005
Special Section: The Critical Path Initiative-Part One
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Ambitious in scale and scope, the Critical Path Initiative provides a rational construct for framing the central paradox of today's new drug and new device development industry.
FDA: Taking the Initiative
August 01, 2005
Special Section: The Critical Path Initiative-Part One
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The Critical Path Initiative (CPI), as it has come to be called, provided the FDA's analysis of the current drug development pipeline problem, characterized by a recent slowdown-instead of the expected acceleration-in innovative medical therapies reaching patients.
Down the Critical Path: Who Should Lead?
August 01, 2005
Special Section: The Critical Path Initiative-Part One
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In March 2004, FDA issued a provocative white paper: Innovation and Stagnation-Challenge and Opportunity on the Critical Path to New Medical Products. The Critical Path was identified by FDA as those parts of the R&D continuum that constitute bottlenecks in the drug development process.
A Call for More Open Collaboration
August 01, 2005
Special Section: The Critical Path Initiative-Part One
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Scientific discovery is, by its very nature, plagued by a lag between concept development and the acquisition of the tools necessary to fully explore a new technology's application.
Critical Path—Build It Collaboratively or Collectively?
August 01, 2005
Special Section: The Critical Path Initiative-Part One
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When the FDA stated that "the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences" everyone seemed to agree.
On-Demand: The Next Generation of Packaging and Labeling
August 01, 2005
Feature Article
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This innovative method increases flexibility, saves money, and supports the Critical Path Initiative.
The Public: A Critical Initiative Partner
August 01, 2005
Special Section: The Critical Path Initiative-Part One
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The FDA's Critical Path Initiative acknowledges long-standing and widely accepted challenges facing the clinical research enterprise and identifies several opportunity areas that may help to address these challenges.