Amy Leiser

Amy Leiser

Associate

Amy Leiser is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device group. She advises pharmaceutical, biotechnology and device companies on a variety of regulatory and compliance issues.

Ms. Leiser is a member of the Bar of Maryland. District of Columbia bar application is pending; supervised by principals of the firm.

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FDA Finalizes Guidance on Medical Product Classification

On September 26, 2017, FDA announced in a Federal Register notice the availability of the final guidance document, Classification of Products as Drugs and Devices & Additional Product Classification Issues.  This guidance provides the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues, such as … Continue Reading
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