FDA approach for liver safety for new drugs

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-FDA approach for liver safety for new drugs

The food and drug administration initiated a sequence of annual meetings to deal with issues of drug induced liver injury. This was due to approval of two drugs troglitazone and bromfenac that led to significant lethal liver toxicity. In the meetings reviewers of new drugs are invited to the meetings and the meetings are opened to pharmaceutical industry, academic consultants to industry, and food and drug administration (Senior, 2014).. The slides shown in the meetings are posted on the internet and availed to the American association for the study of the liver diseases. This has raised awareness on new drugs that result to liver injury.

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The food and drug administration also developed a program called eDISH meaning evaluation of Drug Induced Serious Hepatotoxicity which is useful in examining drug induced liver injury in clinical trial subjects. This has been useful as the food and drug administration has been able to curb hepatotoxicity (Senior, 2014). The food and drug administration however is yet to find a suitable and best way of estimating the probability that a drug in question actually caused the given liver injury. The food and drug administration also carries a yearly educational conference on drug induced liver injury for the food and drug administration reviewers.


Senior, J. R. (2014). Evolution of the Food and Drug Administration approach to liver safety assessment for new drugs: current status and challenges. Drug safety, 37(1), 9-17.

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