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FDA issues draft guidance on remote regulatory assessments

DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records.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

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

Mounting pressure at both federal and state levels to expand PFAS oversight in food packaging

California and Vermont have recently joined a growing list of states that have passed legislation banning the use of per- and polyfluoroalkyl substances (PFAS) in food packaging. Relatedly, a group of environmental, consumer,...more

FDA provides additional time to submit DUNS number as part of the 2020 facility registration renewal

The U.S. Food and Drug Administration (FDA) released a guidance document on 1 December 2020 announcing an enforcement policy related to submission of a facility’s Unique Facility Identifier (UFI) as part of the 2020 biennial...more

HHS announces polices related to future rulemaking procedures

On 24 November 2020, the Department of Health and Human Services (HHS) issued Notices in the Federal Register announcing two new policies related to future rulemaking procedures for all HHS agencies....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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