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August 28, 2015

Remediation Projects

Keeping current with constantly changing regulations can be challenging. In some cases, pharmaceutical companies may find that their practices are not compliant with current guidelines and that remediation measures are necessary. As such, pharmaceutical companies should understand how to develop effective remediation projects. What is A Remediation Project? A remediation project is designed to rectify […]

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Recent changes to the Food and Drug Administration Modernization Act of 1997 have facilitated the review and approval of novel devices. The process of classification of the de novo mechanism is one such change. As such, device manufacturers should understand what a de novo classification is, the circumstances under which its use is appropriate, and […]

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The FDA Group Ranks No. 294 on the 2015 Inc. 500|5000 List with Three-Year Sales Growth of 1,552% WESTBOROUGH, MA, August 12, 2015 — Inc. magazine today ranked The FDA Group No. 294 on its 34th annual Inc. 5000, an exclusive ranking of the nation’s fastest-growing private companies. The list represents the most comprehensive look […]

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One of the challenges that device manufacturers face is determining how to proceed when developing a device. The issue becomes more complicated for devices that do not fit into one definite class. As such, the Food and Drug Administration has established a mechanism in Section 513(g) of the Federal Food, Drug, and Cosmetic Act by […]

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Human factor studies are an integral part of any device or drug delivery system submission. The Food and Drug Administration requires them to fulfill the requirements for device safety. As such, pharmaceutical and medical device executives should understand what human factor studies are, what regulations govern human factor studies, what factors to consider when designing […]

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