- The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by
Deadlines Set for FDA to Establish Reporting Requirements for “High-Risk” Foods
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- The Food Safety Modernization Act (FSMA), enacted on January 4, 2011, set deadlines for the U.S. Food and Drug Administration (FDA) to (1) designate high-risk foods for which additional recordkeeping
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FDA Publishes Draft Guidance to Assist in Developing Alternate Curricula to Satisfy Produce Safety Rule Requirements
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- FDA published a draft guidance to help farmers and educators develop or select alternate curricula to meet the training requirements of the Produce Safety Rule mandated by the Food Safety
Upcoming Presentation on FDA’s 2018 Cyclosporiasis Outbreak Investigations Will Explore Recent Scientific Advances and Continuing Regulatory Challenges
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- Cyclosporiasis is an intestinal illness caused by the microscopic parasite Cyclospora cayetanensis. People can become infected with Cyclospora by consuming contaminated food or water. Past cyclosporiasis outbreaks in the
FDA Extends Application Deadline for VQIP
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- The U.S. Food and Drug Administration (FDA) announced that the application period for importers to submit their notice of intent to participate in the Voluntary Qualified Importer Program (VQIP) for
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Sharpless: ‘No Pause’ Following Gottlieb’s Departure
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- As previously reported on this blog, Ned Sharpless succeeded Scott Gottlieb as Acting FDA Commissioner in April 2019. Prior to Sharpless’ tenure, it was unclear whether the agency would
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FDA Announces “New Era of Smarter Food Safety”
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- On April 30, 2019, Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas announced a “New Era of Smarter Food Safety,” an effort intended to combine
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FDA Announces Enforcement Discretion for Certain Commodities Related to Produce Safety Rule
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- The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce.
FDA Releases Second Installment of Intentional Adulteration Draft Guidance
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- FDA released the second installment of a draft guidance designed to support compliance with the Intentional Adulteration (IA) rRule under the Food Safety Modernization Act (FSMA). The first
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FDA’s Outlines Plans to Modernize Oversight of Imported Food
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- The U.S. Food and Drug Administration (FDA) discusses how the Agency is integrating new tools, that are a result of the passage of the Food Safety Modernization Act (FSMA), with
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