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Home » Topics » Regulatory » FDA

FDA
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FDA Extends Two COVID-19 Temporary Guidances Related to Onsite Visits Abroad Under FSMA

July 13, 2023

The U.S. Food and Drug Administration has reissued two temporary guidances originally published during the COVID-19 public health emergency (PHE) for certain regulatory requirements that involve onsite visits abroad under the Food Safety Modernization Act (FSMA).  


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FDA Updates on Chemical Safety Reassessment Work, Reveals Substances of Agency’s Focus

July 12, 2023

Following a May 2023 announcement of a new framework for systematic post-market reassessment for chemicals used in foods, the U.S. Food and Drug Administration (FDA) has released a public inventory of certain food ingredients and additives determined to have unsafe uses in food because they are unapproved, as well as lists of select chemicals currently under the agency’s review. FDA also shared insights about the agency’s work to enhance the assessment of ingredients in foods on the market.


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FDA Provides Updates on Guidance Priorities for 2023

July 6, 2023

The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) have released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023. The list updates the guidance agenda released in February 2023 and focuses on Level 1 draft and final guidances.


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FDA Provides Updates on Cyclospora Action Plan Efforts

June 30, 2023

The U.S. Food and Drug Administration (FDA) has provided updates on the agency’s Cyclospora Prevention, Response, and Research Action Plan to reflect the current status of the agency’s work to prevent and reduce incidences of foodborne cyclosporiasis in the U.S.


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Rheonix Develops Fully Automated Cyclospora Test in Collaboration with FDA

June 27, 2023

A molecular sample-to-answer method developed by Rheonix Inc. and the U.S. Food and Drug Administration (FDA) enables low-level detection of Cyclospora in food and environmental samples.


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Latest Update on FDA Human Foods Reorganization Reveals Major Changes to ORA

June 27, 2023

The U.S. Food and Drug Administration has provided updates on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA).


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FDA Releases FSMA 204 FAQs, Tools, Resources

June 27, 2023

The U.S. Food and Drug Administration (FDA) has posted answers to frequently asked questions (FAQs) and additional tools to provide industry with more information about the FDA Food Safety Modernization Act (FSMA) Food Traceability Final Rule, also known as FSMA 204. 




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FSMS Strongest Indicator of Compliance in Restaurants, FDA Reports

June 20, 2023

The U.S. Food and Drug Administration (FDA) has published a report on the occurrence of foodborne illness risk factors in fast food and full-service restaurants from 2017–2018. The study found FSMS to be the strongest predictor of compliance, with well-developed FSMSs associated with fewer out-of-compliance food safety behaviors/practice than those underdeveloped or non-existent FSMS.


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Congress Reintroduces Bill Giving FDA Authority to Investigate Corporate Livestock Operations Implicated in Foodborne Illness Outbreaks

June 16, 2023

U.S. Representative Rosa DeLauro (CT-03) has reintroduced the Expanded Food Safety Investigation Act, which would give the U.S. Food and Drug Administration (FDA) the authority to investigate corporate livestock feedlots and confinement operations implicated in foodborne illness outbreaks.


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FDA Reminds Producers of RTE Dips to Adhere to Best Practices After Conducting Salmonella, Listeria Sampling Assignment

June 15, 2023

The U.S. Food and Drug Administration (FDA) recently released the findings of a sampling assignment that collected and tested ready-to-eat (RTE) dips and spreads with the aim of determining the presence of Listeria monocytogenes and Salmonella.


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