Former FDA Medical Officer and FDA’s Subject Matter Expert.
Medical Officers serve on a federal level as a medical officer for the US Food and Drug Administration. As a medical officers advised as an resident FDA expert on applications and queries from drug companies.
Medical Officers as the FDA’s front-line contact individual directly to drug companies applying for new-drug approvals, labeling supplements, et cetera. As a medical officer, are responsible for all major in-house decisions and also gave large-scale presentations and publications on behalf of the entire FDA.
The Merck SEARCH Trial: (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) compared the simvastatin side effects of simvastatin 80mg and simvastatin 20mg. As part of its safety arm, The Merck’s SEARCH trial evaluated the muscle safety/ rhabdomyolysis and efficacy signals between both dosing groups.
The results of this trial were critical since simvastatin 80mg is a commonly prescribed high-dose statin medication, and rhabdomyolysis is a statin side effect that occurs with all seven of the currently available statins approved by the FDA.
Compared to all other statins, simvastatin 80 is the least expensive statin relative to its potency and, therefore, has the most statin side effects because of the relative abundance of postmarketing FDA safety/rhabdomyolysis and efficacy data, since its FDA approval in 1992.
The Merck SEARCH trial completed approximately 12,000 patients over a 6.7 year period. An FDA expert and pharmacology expert/ drug expert are given charge of writing the FDA safety review of the Merck SEARCH trial and presenting the simvastatin side effects, including the muscle safety/ rhabdomyolysis postmarketing and efficacy data findings.
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