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FDA Finalizes Guidance on Conducting Remote Regulatory Assessments

The Food and Drug Administration (FDA) published its final guidance for industry entitled “Conducting Remote Regulatory Assessments – Questions and Answers” on June 26, 2025. Initially published in draft format in July 2022...more

FDA issues draft guidance on remote regulatory assessments

DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more

FDA issues final guidance on oversight of food covered by Systems Recognition Arrangements

This week, the U.S. Food and Drug Administration (FDA) issued final guidance concerning regulatory oversight of food imported from Systems Recognition Arrangement (SRA) countries. FDA employs a Systems Recognition (SR)...more

FDA issues draft guidance on oversight of food products covered by Systems Recognition Arrangements

For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...more

OMB releases Spring 2021 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Spring 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This article...more

FDA to test voluntary “healthy” symbols through consumer research

The U.S. Food and Drug Administration (FDA) has recently signaled its continued interest in developing a voluntary “healthy” symbol for packaged foods as a representation of the nutrient content claim....more

FDA signals uptick in enforcement with market sweep on depression claims

On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more

OMB Releases Spring 2020 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

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