FDA的动态

? ? The 30 April 2024 issue of the European Commission EU Health and Food Safety DG #SANTE "Health and Food Safety Newsletter" is out and available in all EU languages on https://lnkd.in/enZdGHD6. ?? Focusing on #EU #Health policy, Director of Directorate D "Medical Products and Innovation", Rainer Becker, talks about the revised #Pharmaceutical legislation, the new legislation on substances of human origin (#SoHo) and the #MedicalDevices regulations - all initiatives specifically addressed to foster #Innovation and improve #Patient #Safety.

FDA Lists Regulations Under Development and Updates Priority Guidance Topics for Foods Program To increase transparency and assist stakeholders by highlighting its regulatory agenda, the U.S. Food and Drug Administration’s Foods Program has posted a new website listing regulations it plans to publish by October 2024 and longer-term regulations it is prioritizing for publication at a later date. The FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024. The list of guidance topics was last updated in July 2023. https://loom.ly/nmrmaY8 #fda #newwebsite #regulations #foods #foodsprogram

???? On October 17, 2024, the Ministry of Food and Drug Safety (MFDS) of #SouthKorea announced the revised Regulation on Exceptions of Prohibited Labels and Advertisements of Food Function Claims, specifying requirements for general food with functional claims supported by scientific data, which will take effect on January 1, 2025. Please click the link below for more details. #labeling #advertising #claims #foodindustry #regulatorycompliance #regulation

The FDA recently released its updated priority list of food regulatory guidance topics for 2024. FDA Guidance documents represent the agency's current thinking on a specific topic and can therefore facilitate compliance with various complex FDA rules. In this Update, members of Perkins Coie LLP Food Regulatory team highlight notable guidance topics that made this year's list. #FDA?#FoodRegulation?#FoodAndBeverage?#FoodAndBeveragendustry?#CultivatedMeat

FDA launches new website to highlight regulatory agenda, guidance topics https://lnkd.in/dsSJNuDq #Global #Africa #foodsafetyafrica #foodsafety #foodbusiness #foodindustry #foodmanufacturing #foodprocessing #foodhygiene #foodquality #systemsmanagement #laboratory #technology #foodsecurity #news #regulatory #policies #compliance

According to the latest FDA Food Code Adoption Report, at present, only three states and two territories have adopted the most recent version of the code (2022). ???? https://brnw.ch/21wJXg0 #foodsafety #foodindustry #foodservice #FDA #foodcode

US Drug Regulations - History The United States has always been a key market for drug approvals. Most drugs that achieve global recognition are first approved in the US before undergoing subsequent filings elsewhere. The US FDA's approvals set a benchmark, influencing regulatory decisions worldwide. But how did the US FDA establish such a robust and respected process? What historical events shaped US Regulatory Affairs? Let’s explore the origins of these stringent regulations. "The Poison Squad & The Pure Food & Drug Act of 1906" In the late 1800s, the food market was a chaotic landscape. Additives like formaldehyde in milk and candies containing arsenic. Amid this turmoil, Harvey Washington Wiley emerged as a champion for food safety. Determined to protect public health, Wiley formed the "Poison Squad," a group of 12 male volunteers who consumed food additives under controlled conditions. Substances like borax and sodium benzoate were tested for their effects on human health. The results, which showed adverse impacts on the volunteers, were published and presented to the government. Wiley's relentless pursuit of regulation, as detailed in Deborah Blum's "The Poison Squad," led to the passage of the Pure Food and Drug Act of 1906. Despite facing industry pushback and internal opposition, Wiley, along with his steadfast allies, navigated the complexities of turning an idea into enforceable legislation. The Poison Squad’s efforts laid the foundation for the rigorous food safety standards we benefit from today. Their legacy is a testament to the critical battles fought to ensure our food's safety. Let's honor the perseverance and dedication that have shaped our food safety regulations. #FoodSafety #PublicHealth #HarveyWiley #PureFoodAndDrugAct #ThePoisonSquad #USFDA

???? On July 19, 2024, the #Thailand Food and Drug Administration (FDA) released the Regulation on Procedures of Food Serial Number B.E. 2024 with immediate effect, replacing the version issued in 2019 and its following four amendments in 2019, 2020, 2021, and earlier 2024. The Regulation stipulates the application procedures of food serial numbers for different types of foods and specifies the cases subject to approval cancellation. Please click the link below for more details. #foodindustry #marketaccess #regulatorycompliance

??FOOD INDUSTRY NEWS?? The head of the FDA has urged Congress to pass legislation mandating that?food manufacturers test for lead in products?imported to the United States. ?? #lead #fda #foodsafety #foodindustry #newsletter

The FDA’s Purpose: A Reminder from History When we pick up a food item or prescription today, we rarely question its safety. However, the FDA's origins remind us why oversight is crucial. Established in 1938, the FDA responded to dangerous and often deadly lapses in product safety that left the public vulnerable. A defining moment that catalyzed FDA regulation was the 1937 Elixir Sulfanilamide disaster, where over 100 people—many of them children—died from a toxic drug that hadn’t been tested for safety. This tragedy, along with widespread issues with food contamination and mislabeled cosmetics, highlighted the need for accountability. Public outcry spurred Congress to pass the Federal Food, Drug, and Cosmetic Act (FD&C Act), setting the foundation for the FDA’s regulatory authority. This legislation empowered the FDA to ensure that food, drugs, and cosmetics met safety and quality standards, protecting consumers from untested or unsafe products. The FD&C Act requires that pharmaceuticals undergo clinical trials, be proven effective, and carry honest labeling. Food safety practices became mandatory, assuring the public that products are sanitary and accurately labeled. Standards for cosmetics also protect consumers from toxic or mislabeled ingredients. Eighty-five years later, the FDA’s mission remains focused on safety, adapting to new challenges posed by advances in science and technology, including complex drugs and tech-driven treatments. While the products and processes have evolved, the principle remains unchanged: consumer protection and safety are paramount. The history of the FDA serves as a powerful reminder that regulatory standards are essential to maintaining public trust. Today, when we pick up a labeled product or take a prescribed medication, we benefit from decades of regulation designed to protect us. The legacy of the FD&C Act continues to shape a safer, more reliable marketplace, fulfilling the FDA’s mission to safeguard public health. #FDA #PublicHealth #ConsumerSafety #RegulatoryAffairs #FDCA #Pharmaceuticals #FoodSafety #CosmeticSafety #ClinicalTrials #HealthRegulation #HistoryofFDA #ProductSafety #QualityStandards #DrugSafety #RegulatoryCompliance #ElixirSulfanilamide #ConsumerProtection #MedicalHistory #TrustInScience