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Enforcement Discretion Policy for Certain Food Safety Modernization Act Regulations
The U.S. Food and Drug Administration (FDA) announced that they will exercise enforcement discretion for certain provisions in four of...
Jan 05, 2018 | Amy Chang
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment...
The U.S. Food and Drug Administration (FDA) has released a draft guidance for industry on Refusal of Inspection by a Foreign Food...
Jan 03, 2018 | Amy Chang
FDA: The Produce Safety Network: Supporting Regulators and Growers Across the Country
The Produce Safety Network (PSN) supports the efforts of farmers, state regulators, and other key stakeholders to implement the...
Jan 03, 2018 | Amy Chang
Report: FDA’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s...
The U.S. Department of Health and Human Services Office of Inspector General (OIG) has released a report on its reviews of the U.S....
Jan 03, 2018 | Amy Chang
Multistate outbreak of E.coli O157:H7 Infections
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are investigating a multistate...
Jan 03, 2018 | Amy Chang
Food Safety Modernization Act: Explaining How the Voluntary Qualified Importer...
The Food and Drug Administration has released information describing how the Voluntary Qualified Importer Program (VQIP) works. The...
Jan 03, 2018 | Amy Chang
FDA Proposes Exciting Changes to the Female Condom
On Worlds AIDS Day (December 1), the U.S. Food and Drug Administration (FDA) announced that it proposes to not only reclassify the...
Dec 11, 2017 | Kim Rodgers
FDA FSMA Update: Small Entity Compliance Guide for Sanitary Transportation Rule
The U.S. Food and Drug Administration has released a guide to help small businesses understand the requirements of the Sanitary...
Dec 05, 2017 | Amy Chang
Quantitative Risk Assessment of Norovirus Transmission in Food Establishments
Norovirus is the most common cause of widespread and sporadic gastroenteritis. The U.S. Food and Drug Administration (FDA) has...
Dec 05, 2017 | Amy Chang
Enforcement Discretion Policy for Certain Food Safety Modernization Act RegulationsThe U.S. Food and Drug Administration (FDA) announced that they will exercise enforcement discretion for certain provisions in four of the Food safety Modernization Act (FSMA) rules. This means that the FDA does not intend to enforce these provisions as they currently apply to certain entities or activities during this discretion period. This discretion period […] Jan 05, 2018 | Amy Chang |
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign GovernmentThe U.S. Food and Drug Administration (FDA) has released a draft guidance for industry on Refusal of Inspection by a Foreign Food Establishment or Foreign Government. The Food Safety Modernization Act (FSMA) gave the FDA the authority to refuse imported food admission into the United States if the agency is not permitted to inspect the foreign establishment […] Jan 03, 2018 | Amy Chang |
FDA: The Produce Safety Network: Supporting Regulators and Growers Across the CountryThe Produce Safety Network (PSN) supports the efforts of farmers, state regulators, and other key stakeholders to implement the Produce Safety Rule. The rule is aimed at preventing foodborne illnesses associated with produce. Read here about how the Food and Drug Administration (FDA) is working to improve coordination within the FDA as its experts work […] Jan 03, 2018 | Amy Chang |
Report: FDA’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food SupplyThe U.S. Department of Health and Human Services Office of Inspector General (OIG) has released a report on its reviews of the U.S. Food and Drug Administration (FDA) oversight of food recalls. After a review of 30 voluntary food recalls, the OIG stated that the “FDA did not always have an efficient and effective food-recall […] Jan 03, 2018 | Amy Chang |
Multistate outbreak of E.coli O157:H7 InfectionsThe Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are investigating a multistate outbreak of Shiga toxin-producing E. coli O157:H7 infections (STEC O157:H7) in 15 states. States affected by the outbreak include California, Connecticut, Illinois, Indiana, Maryland, Michigan, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Virginia,... Jan 03, 2018 | Amy Chang |
Food Safety Modernization Act: Explaining How the Voluntary Qualified Importer Program Will WorkThe Food and Drug Administration has released information describing how the Voluntary Qualified Importer Program (VQIP) works. The information includes why importers should enroll in the program, how it benefits importers, the FDA, and the public health. Learn more here. Jan 03, 2018 | Amy Chang |
FDA Proposes Exciting Changes to the Female CondomOn Worlds AIDS Day (December 1), the U.S. Food and Drug Administration (FDA) announced that it proposes to not only reclassify the female condom from a Class III to a Class II medical device, but to also de-gender the device through renaming it the “single-use internal condom.” The proposed order also calls for expanding the indication […] Dec 11, 2017 | Kim Rodgers |
FDA FSMA Update: Small Entity Compliance Guide for Sanitary Transportation RuleThe U.S. Food and Drug Administration has released a guide to help small businesses understand the requirements of the Sanitary Transportation of Human and Animal Food rule. Small businesses are expected to comply by April 6, 2018. The guide includes information on who is covered by the rule in an easy-to-read format and includes information […] Dec 05, 2017 | Amy Chang |
Quantitative Risk Assessment of Norovirus Transmission in Food EstablishmentsNorovirus is the most common cause of widespread and sporadic gastroenteritis. The U.S. Food and Drug Administration (FDA) has developed a quantitative risk assessment model to quantify and study the risk association with the transmission of norovirus to consumers through contamination by infected food handlers in retail foods. Learn more about the risk assessment model […] Dec 05, 2017 | Amy Chang |
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