Please answer to this discussion post. At least two paragraphs with a minimum of two references, APA style and plagiarism. 

-In 1997, two drugs, bromfenac and troglitazone, prompted the Food and Drug Administration (FDA) to begin a cycle of yearly conferences to review issues of drug – induced liver injury (DILI). This was after the two drugs had shown serious fatal liver toxicity. Drug application reviewers were the first invitees to the conference in 1999. Academic consultants and pharmaceutical industry were later involved in 2001. As a result, FDA released a guidance entitled: “Guidance for Industry Drug-Induced Liver Injury: Premarketing Clinical Evaluation” (Senior 2014). This presentation was a rational approach was meant to assist in assessment of liver safety in clinical trials.

FDA identified DILI as a key area of focus in a joint effort to broaden the industry’s knowledge in liver toxicity. Since the guideline in 2009, DILI has been the main cause of most drug marketing withdrawals. FDA proposes standard non-clinical toxicity as the cornerstone for preventing hepatotoxicity in humans despite their predictive power being unsatisfactory (Senior 2014). As such, new tests with improved sensitivity and specificity are needed are required to predict hepatotoxicity in clinics.

The guidance describes observations needed to evaluate indicators of hepatotoxic potential. According to Senior (2014), these observations include detection, reaffirmation and examining of liver test abnormalities. The industry then does close evaluation excluding other possible caused of liver toxicity. Lastly, the FDA guidance requires the industry to those affected. This largely involves supportive care till return to baseline status or normality. FDA also makes specific recommendations in the presentation on why some people are more susceptible to DILI. It proposes the use and evaluation of Hy’s Law cases that are discovered through clinical examination. 

Reference

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.

Please respond to this post with a minimum of two paragraphs with two references, APA style, and no plagiarism. 

-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.

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.

Reference

 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.