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Drug Efficacy Study Implementation

What Does Drug Efficacy Study Implementation Mean?

Drug efficacy study implementation (DESI) is a process used to determine the effectiveness of existing drugs on the market. Efficacy is defined as the ability to produce a desired or intended result. Thus, this process is not about determining the safety of a product, but rather the ability of the product to perform it's intended purpose effectively. The American Food and Drug Administration (FDA) have enacted the DESI solution to ensure all products on the market do what they say.

Safeopedia Explains Drug Efficacy Study Implementation

In 1938 The Federal Food, Drug and Cosmetic Act (FD&C) was established to ensure that drugs must be proven safe before they are available on the market. In 1962, the Kefauver-Harris Amendments to the Act required that drugs also be proven efficacious, or having the effect they claim to an efficient degree, before approval. Between 1938 and 1962, many drugs had already been released that met the safety requirement, but did not meet the efficacy requirement. This meant that these products had to be reviewed and approved. The FDA then setup the DESI process. This was a process of reviewing products in circulation and publishing findings in a list. This was due to the fact that the FDA did not have the resources to change these existing products or take them off the market. These are published in a federal register, which is, unfortunately, never quite complete and is always a work in progress with many products still under review.


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