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Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation

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Tools for Faster Drug and Device Development
FDA’s New Pathways to Innovation

Speed and efficiency of the drug and device development processes has long been a concern of the FDA.

Manufacturers that are using new and unique development tools, such as biomarkers, can apply to the agency’s development tool qualification program to have them approved for use in other development efforts.

According to CDER Director Janet Woodcock a national repository of tools approved by the FDA will accelerate the development of new products because researchers will not have to prove a tool’s reliability every time they use it.

In Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation noted FDA law expert Jim O’Reilly lays out the current landscape of drug and device development tool research. He explains how the 21st Century Cures Act has established an updated, multi-stage process for development tool qualification and explores how the FDA will implement it. You’ll learn:

  • What the FDA means by “qualified” data

  • Standards the agency may set for approval of such tools as biomarkers and clinical outcomes assessment

  • How to show that new tools can identify safety risks as well as prove efficacy

  • Procedures for pre-filing meetings

  • The impact of adverse events

Tools for Faster Drug and Device Development will help drug- and devicemakers increase the speed and efficiency of the development process and get vital new products to the public.

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  • Researchers
  • R&D department
  • Regulatory affairs
  • Corporate strategists

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