Regulatory Clarity, Communication, and Nimbleness

Publication Date: December 2022

The United States is at the forefront of the biotechnology revolution, and its regulatory agencies are and will continue to be tasked with establishing and enforcing rules and regulations that ensure the commercialization of biotechnologies that are viable and economically-sound solutions and do not present unacceptable risk. Herein we articulate select areas of uncertainty and concern that have caused challenges in the development of biotechnologies.

Executive Order: Section 8 – Biotechnology Regulation Clarity and Efficiency.

Keywords: regulations, biotechnology, communication, regulatory clarity, regulatory landscape, innovation, horizon scanning, coordination, engineering biology, Executive Order

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