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Modernizing the Regulatory System for Biotechnology Products

The White House has posted a blog (January 4, 2017) unveiling the final version of the Update to the Coordinated Framework for the Regulation of Biotechnology as well as information on the National Strategy for Modernizing the Regulatory System for Biotechnology Products. View the blog announcing these documents

The national strategy and update of the coordinated framework are part of the Administration’s continuing effort to modernize the federal regulatory system for biotechnology products as well as clarify various roles of the Environmental Protection Agency, Food and Drug Administration and Department of Agriculture in evaluating new biotechnologies:

  • Update to the Coordinated Framework for the Regulation of Biotechnology to clarify current roles and responsibilities. View the update to the coordinated framework.
  • National Strategy for Modernizing the Regulatory System for Biotechnology Products to set forth a vision for ensuring that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology. Read this national strategy

This Update and the accompanying Strategy offer the public a complete picture of a robust and flexible regulatory structure that provides appropriate oversight for products of modern biotechnology.

Background

On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum directing the primary agencies that regulate the products of biotechnology—the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)—to update the Coordinated Framework for the Regulation of Biotechnology, develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort.  View the memorandum directing this regulatory update

As part of this process, the Administration announced that it would hold three public engagement sessions in different regions of the country:

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