FDA Weighs in on Drug Development Tools

Hui jing yu | March 18, 2014

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Drug development tools (DDTs) are methods, materials or measures that help to accelerate drug development and can be applied to a broad range of products and therapeutic areas. As part of the FDA's Critical Path Initiative (CPI), the Center for Drug Evaluation and Research (CDER) has undertaken multiple initiatives to support the development of new DDTs. Among these is the creation of a formal qualification process which details the kinds of data that should be submitted by a sponsor to support qualification of a DDT.

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Nexus Pharmaceuticals, Inc.

Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.

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