FDA Proposes Food Defense Rule to Protect Against Intentional AdulterationRobert G. Hibbert
The FDA said it does not know of any cases where the food supply was intentionally tainted with the aim of inflicting widespread harm, and added that such events are unlikely to occur. However, the new rule is apreventive measurethat would help ensure the safety of the food supply. "The ...
法规变化：FDA近年来加强了对食品防御（Food Defense）的管理，要求企业在生产过程中防范可能的故意污染行为。根据《食品防御规则》（Intentional Adulteration Rule），企业需制定食品防御计划，特别是对可能受到意图性破坏的生产和储存环节实施安全防护。解读及应对建议：企业应在生产设施中建立食品防御措施，进行“关键点分...
7 C. Do I have to comply with the requirements of the IA rule if I am not required to register with the FDA? 9 D. Am I exempted from the rule if my firm is a very small business? 9 III. WHEN DO I HAVE TO COMPLY WITH THE RULE? 9 IV. FOOD DEFENSE MEASURES 10 A. Food ...
Despite the best efforts of food safety and food defense professionals, contaminated food continues to enter the food supply. It is imperative that contami... T Bhatt,JJ Zhang - 《Journal of Food Science》 被引量: 6发表: 2014年 Food Safety and Traceability Foodborne illness cause significant ...
美国FDA 指导原则 联邦食品、药物和化妆品法案Hatch-Waxman修正案规定的180天仿制药排他性 英文原版.pdf,Guidance for Industry 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act U.S. Department of Hea
Still, Merrigan said the FSMA has the potential to be a “real game-changer” for agriculture. For one thing, it’s the largest food safety overhaul in 70 years, and the new law will provide producers a new line of defense against food safety issues.Sustainable agriculture. One...
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B)....
Inside Health Policy, FDA Week | Lawyer Expects Trump to Use DPA for Non-Meat Food Industry if Needed Angela Spivey comments on the government’s possible use of the Defense Production Act throughout the food supply chain, including facilities regulated by the U.S. Food and Drug Administration...
WASHINGTON (The Hill) – The Food and Drug Administration (FDA) is proposing a rule to offer a new category of over-the-counter hearing aids in an attempt to boost accessibility and lower costs for the devices for Americans. The agencyannounced its proposalon Tuesday that would allow certain...