Surveillance Approaches for Regulatory Science
Susie Y. Dai
Abstract
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Susie Y. Dai
Abstract
Open-access reader
The essential function of a regulatory agency is to enforce laws enacted by the government and regulations established by the agency. For example, the US Food and Drug Administration (FDA) is charged with protecting public health by the regulation of food; pharmaceuticals, both over-the-counter and prescription; dietary supplements; medical devices; animal feeds; and veterinary medications. The effective regulation requires fit-for-purpose surveillance activities. Designing surveillance activities based on scientific theory and management through a science-based approach provides a repeatable and verifiable framework for iteratively gathering and analyzing data, and developing increasingly effective risk-mitigation techniques to support regulatory programs.https://doi.org/10.21423/jrs-v04n01pi (DOI assigned 7/23/2019)
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The essential function of a regulatory agency is to enforce laws enacted by the government and regulations established by the agency. For example, the US Food and Drug Administration (FDA) is charged with protecting public health by the regulation of food; pharmaceuticals, both over-the-counter and prescription; dietary supplements; medical devices; animal feeds; and veterinary medications. The effective regulation requires fit-for-purpose surveillance activities. Designing surveillance activities based on scientific theory and management through a science-based approach provides a repeatable and verifiable framework for iteratively gathering and analyzing data, and developing increasingly effective risk-mitigation techniques to support regulatory programs.https://doi.org/10.21423/jrs-v04n01pi (DOI assigned 7/23/2019)
Key concepts: Regulatory science, Agency (philosophy), Food and drug administration, Government (linguistics), Business, Regulatory agency, Function (biology), Medical prescription