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It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.
The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.
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This article discusses Non-Biological Complex Drugs (NBCDs) and how FDA and other regulatory agencies review and approve generic forms of these products.
Categories: Generic drugs, Regulatory strategy, Submission and registration, Features, US, FDA
Tags: Non-Biological Complex Drugs, NBCD
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Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible." View More
The US Food and Drug Administration (FDA) on Friday issued a final rule banning powdered medical gloves beginning on 19 January 2017. View More
The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs). View More
In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name. View More