Mingham Ji

Mingham Ji is an associate in the firm’s Washington, DC office, where she is a member of the Food and Drug and Anti-Corruption practice groups. Ms. Ji advises food, dietary supplement, pharmaceutical, and biotechnology companies on regulatory and compliance issues.

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Significant FDA Digital Health Policy Development for Prescription Drug Sponsors

As previewed by Commissioner Gottlieb several months ago (see our earlier post here), FDA published a notice in the Federal Register on November 20, 2018, to propose a new framework for “prescription drug-use-related software.” The Agency defines this digital health category widely as software disseminated by a prescription drug sponsor for use with the sponsor’s … Continue Reading

FDA Finalizes General Wellness Guidance

By Mingham Ji on August 5, 2016 Posted in Medical Apps, Medical Devices and FDA

In a new post on Covington’s InsideMedicalDevices blog, we provide an analysis of FDA’s newly issued final guidance document entitled “General Wellness: Policy for Low Risk Devices.” To read the post, please click here.… Continue Reading