food supply. The user friendly platform within the FDPB software guides users through the process of creating an action plan. The tool also efficiently combines other previously released tools from the FDA such as food defense guidance documents, the Vulnerability Assessment Software Too...
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
• National agriculture and food defense strategy 国家农产品和食品防护战略 • Consortium of laboratory networks 建立实验室网络 • Easier to find recall information 方便查找召回信息 Implementation: FDA is prepared 实施:FDA准备就绪 • Experience in preventive controls ...
labeling, and promotion including compliance with NLEA and GRAS determinations. We have advised our clients on the various FSMA rules and how to implement and adopt best practices as outlined in various corresponding FSMA guidance documents.
The draft update includes two new Q&As which (1) clarify that nutrition information can be provided on third party platforms (TPPs) through which food is ordered and delivered and (2) that added sugars may voluntarily be declared. Although FDA accepts comments on any guidance at any time, co...
The US Food and Drug Administration (FDA) and the US Department of Defense (DoD) have launched a joint program to fast-track development of medical products for military personnel, akin to the FDA's breakthrough designation program, which expedites important new products for the general populatio...
preventive controls, maintain written food safety plans, register facilities with FDA and review Global Food Safety Initiative certification. Additionally, our attorneys can provide guidance on food labeling requirements, such as Nutrition Facts panels and allergen declarations, and address specific ...
FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the ...
Posted inDraft Guidance,FDA On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Ques...
and other contaminants. The FDA regulates ingredients, additives, packaging, allergens, dietary ingredients, dietary supplements, and labeling of foods; and provides guidance manuals and regulatory information for facilities, CGMPs, and HAACP protocols for food processors, as well as for all retail food...