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Online7/15/2015 - 8/19/2015
Foster City, CA8/7/2015
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Over the past two decades, the US Food and Drug Administration’s (FDA’s) Center for Drug and Evaluation and Research (CDER) has been developing new, expedited pathways to help bring innovative medical products to market more efficiently. These pathways include fast track designation, accelerated approval, priority review and, more recently, breakthrough therapy. Through these expedited pathways, some products have been approved with fewer clinical data than traditionally are required.
While the Congress is busy working on the 21st Century Cures Act, which is expected to speed access to new drugs and devices, a new report from EP Vantage shows FDA isn't sitting on its hands.
Last week, the US Food and Drug Administration announced the release of a new report, FDA Science Moving Forward, showcasing the agency's scientific advancements since 2007.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.
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Monday, the US Food and Drug Administration (FDA) released a draft guidance detailing how it plans to use quality metrics to improve its ability to conduct risk-based inspections and predict or mitigate potential drug shortages. View More
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter. View More