Developing a Successful Regulatory Strategy for Mobile Health Devices and Applications

For many technology companies entering the mobile health space, meeting US Food and Drug Administration (FDA) requirements may be unfamiliar territory. The Covance Mobile Health Blogguidelines can appear convoluted and contradictory at first glance, and some devices and/or applications (apps) fall into regulatory grey areas.

To make progress in this rapidly changing field, companies need to find a way to work within the regulations while encouraging creative development. Consulting with experts and the FDA, considering key design issues, taking precautionary quality measures and assessing global requirements will increase the chances that a company can bring a safe and successful mobile health device and/or app to market.

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FDA Takes Final Step On Manufacturing Standards of Infant Formula

FDA Takes Final Step On Manufacturing Standards of Infant FormulaAn estimated 1 million infants in the U.S. are fed formula from birth, and by the time they are three months old, about 2.7 million rely on formula for at least part of their nutrition.

On June 9, 2014 the U.S. Food and Drug Administration released a final rule regarding the manufacturing standards of infant formula. The final rule—which amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufactures of infant formulas—is meant to ensure that formulas for infants without unusual medical or dietary problems are safe and support healthy growth. The rule also establishes current good manufacturing practices (CGMPs), and sets a date of September 8, 2014 for manufacturer compliance. Continue reading

Shaping Global Standards for Bioanalysis

Global Bioanalysis ConsortiumWhen we provide sample concentration data for submission with new drug applications, clients have an expectation that those data will meet regulatory agency expectations for quality, accuracy, and precision. Those expectations have been evolving since the first US consensus AAPS/FDA workshop (Crystal City I) in 1990. Subsequent workshops and the resulting white papers have formed the basis for guidance documents on conducting method validations and sample analysis. These documents are published by regulatory agencies such as the US FDA and the European Medicines Agency. Continue reading