FDA Pre-Cert Pilot for Medical Software: Key Questions and Eligibility Criteria
August 17, 2017
By Neozene

Following the rollout of a pre-certification pilot program for digital health technology and software developers, the US Food and Drug Administration has identified and answered several frequently asked questions regarding participation. The FDA’s new FAQ covers key aspects of the agency’s new Pre-Cert for Software pilot program, intended to allow access for qualifying digital health product developers to the US market without extensive premarket review. Pertinent deadlines for Pre-Cert participation US regulators opened the Pre-Cert program to voluntary participants starting August 1, 2017, and plan to begin the program on September 1, 2017; nine

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Amazon could partner with a PBM to blaze its trail into pharma
August 15, 2017
By Neozene

Word is tech giant and retail category-killer Amazon might jump into the drug business. While the company itself hasn’t revealed any plans, a new Goldman Sachs report details just how the company might look to shake things up for pharma, with an initial eye on the supply chain. Goldman believes Amazon would focus on drug middlemen that seem at first glance to be “‘primed’ for disruption.” But as the analysts note in their 30-page report, a few big players dominate the sector and it’s tough to scale up enough to compete. Plus,

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Quality Practices Boost Profits and Efficiencies
August 10, 2017
By Neozene

Continuous improvement practices and initiatives have a direct, positive impact on an organization’s finances, according to senior executives and quality professionals surveyed in March by ASQ and Forbes Insights, the research arm of Forbes media. The results of the survey, featured in “The Rising Economic Power of Quality: How Quality Ensures Growth and Enhances Profitability,” shows that organizations embracing formal quality initiatives are more likely to attain higher levels of productivity than those that aren’t. The research draws on responses from 1,000 senior executives and nearly 900 quality professionals from around the

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