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The Life Sciences Lab

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Jan. 24, 2023

FDA Reveals Planned 2023 Regulatory Actions

By Christopher Hanson

The Biden Administration issued the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions (the Unified Agenda) earlier this month.

Typically published twice a year in the spring and the fall by the Office of Information and Regulatory Affairs (OIRA), the Unified Agenda includes contributions from federal agencies regarding planned short- and long-term rulemaking actions. Short-term actions are those activities that an agency expects to complete within the next 12 months. Long-term activities are under development, but an agency does not expect to complete action within 12 months.

In the current Unified Agenda, the U.S. Food and Drug Administration (FDA) lists 74 short-term actions, including 47 proposed rulemakings and 27 final rulemakings. FDA also includes 13 long-term actions. The short- and long-term actions fall across all FDA regulated product categories, including drugs, biologics, medical devices, conventional foods, dietary supplements, animal products, cosmetics, tobacco products, and radiation-emitting electronic products.

The Unified Agenda is a helpful tool in identifying upcoming opportunities for industry to submit public comments on Advance Notices of Proposed Rulemaking (ANPRs) as well as proposed rules and to plan any additional advocacy activities. The Unified Agenda also alerts the public to when FDA intends to finalize a particular rulemaking, enabling industry to anticipate potential new regulatory requirements.