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Therapeutic Development Process

The Drug Testing and Approval Process and Timeline

The process of testing and approving drugs is broken into four phases: drug discovery, preclinical testing, clinical trials and FDA review.

Due to high attrition rates, mainly during preclinical translation, bringing one new drug to market comes at a high cost in terms of time and resources, and in the human cost to patients and their families. One drug typically involves the investigation of up to 10,000 compounds and takes about 14 years to be approved. NCATS aims to eliminate the bottlenecks in the translation process.

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