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How much does a warning letter actually cost? It’s an important question, but an almost impossible one to answer confidently. Along with the direct costs of remediation, there are a variety of intangible expenses that simply can’t be quantified in full. Add to this the fact that companies incur different expenses depending on the particular […]

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In 2015, the FDA released their Request for Quality Metrics draft guidance, describing the measurements they’ll use to evaluate the quality of drug and biologic manufacturing. But despite the many resources FDA has made available to help educate manufacturers on the use of collected data, companies are still struggling to understand what exactly the Agency […]

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To most hospitals and physicians, the Centers for Medicare and Medicaid Services’ (CMS) Meaningful Use program has been a disaster. In the push to improve patient care, Meaningful Use incentivized the use of electronic health records (EHRs) in coordination with MACRA. In 2015, controversy turned to frustration as the program began issuing penalties to those […]

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By the end of 2016, the FDA aims to increase pre- and post-market regulatory decisions using real-world evidence by 40 percent compared to 2015’s baseline. Next year, the goal expands to 100 percent. For medical device manufacturers, that means a considerable shift away from relying mainly on clinical trials and instead focusing more on data […]

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The FDA recently released the Center for Devices and Radiological Health’s (CDRH) Strategic Priorities guide highlighting the accomplishments they’ve made over the past two years, and more importantly, the main objectives for the years ahead. We’ve pulled out the three key objectives for 2016 and 2017 from the 12-page paper and summarized them below.

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