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The road to drug approval is rarely a short or smooth one.
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Main outcomes and measures: ODAC recommendation for drug approval and subsequent FDA approval.
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A drug approval decision can make or break a small company.
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It could shave years off the traditional drug approval process.
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It was the second controversial drug approval for Sarepta.
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Participants were given background information about antibiotic resistance, streamlined drug development programmes and FDA drug approval processes.
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This is likely due to differences between patient populations treated immediately after drug approval and those treated later.
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Conclusions and relevance: Availability of multiple trials is associated with higher odds of ODAC recommendation and drug approval.
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He cited supportive government policies, less cumbersome drug approval procedures, and an influx of capital into the healthcare sector.
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Healthcare stocks were the only bright spot in the market after a U.S. Supreme Court hearing and a cancer drug approval.
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However, drug approval and health technology assessment agencies have stressed that surrogates should only be used in the absence of clinical endpoints.
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The studies were so-called observational studies and not the gold standard of randomly-controlled clinical trials typically used to win new drug approval.
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Guardant360 is used for a range of applications, including translational science research and identifying target patient populations, drug development and commercialization post- drug approval.
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Over the past year, these striking data led to major changes in advanced MCC therapy, including the first-ever FDA drug approval for this disease.
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Phase III is the final stage of testing on patients before an application can be made for drug approval by the Food and Drugs Administration.
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In their appeal, the Justice Department argues that the order "interferes with and thereby undermines the regulatory procedures governing the FDA's drug approval process."