FDA Creates Program to Boost Regulatory Science, Speed Drug Development

Posted 05 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is announcing the launch of a new program that it hopes will help to advance clinical trial design and endpoints to boost regulatory science and facilitate expedited drug development.

The program, which FDA is calling the Drug Development Tools (DDTs) Qualification Program, is being run by FDA's Center for Drug Evaluation and Research (CDER). The Center sees the program as "a mechanism for formal review by CDER to qualify drug development tools, and provide a framework for interactions with the Center to better identify data needed to support qualification of these tools."

FDA explains the program deals with three types of drug development tools: biomarkers, clinical outcomes assessments and animal models used under the Animal Rule.

The qualification tests, once validated by FDA, will be relied upon to test drugs for surrogate measures of safety and efficacy.

Read more:

FDA - Qualification program may facilitate drug development through novel tools

FDA - Drug Development Tools (DDT) Qualification Programs

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