United States Department of Veterans Affairs
VA National HIV/AIDS Website

How Long Before a Drug is Approved by the FDA?

for Veterans and the Public

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How long does the FDA take to approve a drug?

It usually takes about 10 years for a drug to be developed and approved for prescription. Many people would like to take the newest medicine as soon as it is proven to work. However, even after a drug has been successful in a Phase III trial, it still may take six to 12 months before that drug is approved for prescription.