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news.BioPharma Services USA, Inc. (BioPharma) has been awarded a 5-year, $20m contract with the Center for Drug Evaluation and Research (CDER), a division of the US Food and Drug Administration (FDA).
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BioPharma Services CEO Renzo DiCarlo said: "We are very proud to work with the FDA in support of their Generic Drug programs. This award is a great example of BioPharma’s capabilities as a leading industry expert in Bioequivalence and Early Stage clinical research."
The FDA studies conducted by BioPharma will allow CDER to proactively address scientific questions in developing generic approval standards and ensure post-market safety and efficacy of approved generic drug products. Ultimately, the outcome of these studies will help improve the generic review practice within CDER.
As part of this contract, BioPharma will provide the FDA with a full service offering from study design inception to clinical conduct, bioanalysis and final report.
BioPharma Services COO Brent Matthews said: "I am certain that our outstanding regulatory history with the FDA and our team’s extensive expertise in the conduct of Bioequivalence trials played a major role in landing this important contract with the FDA."