The Legal Environment for Precision Medicine.

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Abstract

The Food, Drug, and Cosmetic Act ("FDCA") establishes the basic regulatory framework for the regulation of drugs and medical devices (including diagnostic tests), and works in combination with the Public Health Service Act ("PHSA") to establish the basic framework for regulation of biological products (e.g., vaccines and cellular therapies). Over time, FDA has built on this framework using regulations, guidance, and precedent to provide the current system we have today. In this article, we give a brief overview of the current US FDA legal environment surrounding some important areas in precision medicine, and discuss changes on the horizon that could have an important impact on its future. This article is protected by copyright. All rights reserved.