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. 2024 Jan 18:12:1354743.
doi: 10.3389/fbioe.2024.1354743. eCollection 2024.

Improving regulatory efficiency for biotechnology products

Muffy Koch  1 , Matthew G Pence  1 , Jaylee DeMond  1 , Gary Rudgers  1
Affiliations

Improving regulatory efficiency for biotechnology products

Muffy Koch et al. Front Bioeng Biotechnol. .

Abstract

Small procedural changes in how regulatory agencies implement biotech policies can make significant differences in improving regulatory efficiency. This paper discusses how science based, crop specific guidance documents can improve dossier content and the review and approval of biotech varieties. In addition, we describe how the adoption of established risk assessment methodology and applying policy-linked decision making at the agency level can boost both efficiency and developer, public and government confidence in agency decision making and in biotech crops.

Keywords: data requirements; decision making; regulation; regulatory efficiency; risk assessment.

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Conflict of interest statement

Authors MK, MP, JD, and GR were employed by J. R. Simplot Company.

Figures

FIGURE 1
FIGURE 1
Hierarchy of legal instruments and time to implementation.
FIGURE 2
FIGURE 2
Risk assessment methodology.
See this image and copyright information in PMC

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