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{ Tag Archives } Serious Skin

Regulatory Science Update: FDA And International Serious Adverse Events Consortium Complete Third Data Release

The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs). The data focus on the genetics associated with DILI and SSR and may help researchers to better predict an individual’s [...]

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Tibotec, FDA Update Warning Label On HIV Drug’s Risk Of Severe Skin Reaction

Tibotec Therapeutics, a unit of Johnson & Johnson, “has strengthened a warning about serious skin reactions in patients treated with the company’s HIV drug Intelence,” the FDA and the company said on Wednesday, Reuters reports.

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FDA And International Serious Adverse Events Consortium Release First Data On Genetic Basis Of Adverse Drug Events

The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal [...]

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