Good news! The FDA has announced the Over-the-Counter (OTC) Drug Monograph Facility Fee for Fiscal Year 2026, with fees nearly halved!
The FDA has officially announced the fee standards for Over-the-Counter (OTC) Drug Monograph facilities for Fiscal Year (FY) 2026. Compared to the previous year, the fees for 2026 have been significantly reduced by nearly 50%%, with the Monthly Dispensing Fee (MDF) facility fee dropping to $19,188$. This favorable news is mainly attributed to the offset of surplus funds and an increase in the number of registered facilities. This article provides a detailed comparison of the fee differences between FY 2025 and FY 2026 and lists the key payment deadlines to help businesses comply and reduce their burden.
2024-2025 Cosmetics Company Registration Service Summary
2025 Cosmetics FDA Registration Annual Summary: In the first year of MoCRA implementation, our company has completed facility registrations, product listings, and compliance guidance for 77 cosmetic companies, and provides bi-annual renewal reminder services.
How can Yunnan's foreign trade enterprises leverage government subsidies to efficiently complete US FDA registration?
Yunnan Province's foreign trade enterprises are ushering in the best window period for exporting to the United States. With the launch of FDA international registration subsidy policies by business departments in various regions, enterprises can significantly reduce the FDA registration costs for food, medical devices, cosmetics, and pharmaceutical companies through government funding. This guide, provided by Feroza Technology, combines the latest policies with FDA compliance requirements to systematically analyze how Yunnan enterprises can complete key stages such as FDA registration, 510(k), MoCRA, and NDC at the lowest cost and highest efficiency, comprehensively enhancing their global market competitiveness.
2025 Annual Summary of Registration Services for Pharmaceutical and Medical Device Enterprises
2025 Company Service Summary: Provided FDA registration for 171 medical device companies and 56 pharmaceutical companies
The FDA will fully resume normal operations.
📢 Background: Risk of US Government Shutdown Averted. Recently, the US Senate completed a series of key votes, officially passing the Continuing Appropriations and Extensions Act. ...
FDA FY 2026 Funding Lapse: Key Considerations for Companies and Industries
Background: According to the FDA's official website, if during the period between October 1, 2025, and before the FY 2026 appropriations are passed or a Continuing Resolution is passed (i.e., the “lapse period”), the FDA...
FDA 推出化妆品不良事件实时报告仪表板，透明度大幅提升
美国 FDA 于 2025 年 9 月 12 日上线了“化妆品不良事件实时报告仪表板”（FAERS Public Dashboard for Cosmetic Products），依据 MoCRA…
DMF备案资料清单详解 | FDA药品主文件准备全攻略
药品 DMF（Drug Master File）备案是进入美国市场的关键环节，企业需准备完整资料以满足 FDA 要求。本文梳理 DMF 备案所需文件、注意事项及合规建议，助力企业高效完成备案流程。
FDA释出“放射性电子产品上市”常见问题指南
FDA通过“放射性电子产品上市常见问题”指南，详细解答产品安全标准、报告要求、进口申报及制造合规要点，帮助企业顺利进入美国市场并确保使用者免受不必要射线风险。
FDA 加强执行“未获批准药品”打击政策
FDA 正在加大对“未获批准药品”（unapproved drugs）的打击力度，采用风险导向执法策略，优先清除存在安全隐患或缺乏疗效证据的药品，保护患者健康并确保市场用药质量。
How can Yunnan's foreign trade enterprises leverage government subsidies to efficiently complete US FDA registration?
Yunnan Province's foreign trade enterprises are ushering in the best window period for exporting to the United States. With the launch of FDA international registration subsidy policies by business departments in various regions, enterprises can significantly reduce the FDA registration costs for food, medical devices, cosmetics, and pharmaceutical companies through government funding. This guide, provided by Feroza Technology, combines the latest policies with FDA compliance requirements to systematically analyze how Yunnan enterprises can complete key stages such as FDA registration, 510(k), MoCRA, and NDC at the lowest cost and highest efficiency, comprehensively enhancing their global market competitiveness.
食品合规启动与核心要求解析
美国 FDA 发布《How to Start a Food Business》指南，全面阐述创业者启动食品业务需遵守的监管要求，包括设施注册、标签规范、生产控制、风险管理及进口申报等。本文提炼核心内容，并提供专业注册服务链接，助力企业快速合规进入美国市场。
Good news! The FDA has announced the Over-the-Counter (OTC) Drug Monograph Facility Fee for Fiscal Year 2026, with fees nearly halved!
The FDA has officially announced the fee standards for Over-the-Counter (OTC) Drug Monograph facilities for Fiscal Year (FY) 2026. Compared to the previous year, the fees for 2026 have been significantly reduced by nearly 50%%, with the Monthly Dispensing Fee (MDF) facility fee dropping to $19,188$. This favorable news is mainly attributed to the offset of surplus funds and an increase in the number of registered facilities. This article provides a detailed comparison of the fee differences between FY 2025 and FY 2026 and lists the key payment deadlines to help businesses comply and reduce their burden.
How can Yunnan's foreign trade enterprises leverage government subsidies to efficiently complete US FDA registration?
Yunnan Province's foreign trade enterprises are ushering in the best window period for exporting to the United States. With the launch of FDA international registration subsidy policies by business departments in various regions, enterprises can significantly reduce the FDA registration costs for food, medical devices, cosmetics, and pharmaceutical companies through government funding. This guide, provided by Feroza Technology, combines the latest policies with FDA compliance requirements to systematically analyze how Yunnan enterprises can complete key stages such as FDA registration, 510(k), MoCRA, and NDC at the lowest cost and highest efficiency, comprehensively enhancing their global market competitiveness.
2025 Annual Summary of Registration Services for Pharmaceutical and Medical Device Enterprises
2025 Company Service Summary: Provided FDA registration for 171 medical device companies and 56 pharmaceutical companies
DMF备案资料清单详解 | FDA药品主文件准备全攻略
药品 DMF（Drug Master File）备案是进入美国市场的关键环节，企业需准备完整资料以满足 FDA 要求。本文梳理 DMF 备案所需文件、注意事项及合规建议，助力企业高效完成备案流程。
FDA 加强执行“未获批准药品”打击政策
FDA 正在加大对“未获批准药品”（unapproved drugs）的打击力度，采用风险导向执法策略，优先清除存在安全隐患或缺乏疗效证据的药品，保护患者健康并确保市场用药质量。
FDA 发布 2025 财年 OTC Monograph 药品用户费标准
美国 FDA 于 2025 财年发布了 OTC Monograph 药品用户费标准，涵盖设施费和 OTC Monograph Order Request（OMOR）费。本文将详细解读 2025 财年的收费标准、缴费时间及合规要求，帮助企业顺利履行合规义务。
2024-2025 Cosmetics Company Registration Service Summary
2025 Cosmetics FDA Registration Annual Summary: In the first year of MoCRA implementation, our company has completed facility registrations, product listings, and compliance guidance for 77 cosmetic companies, and provides bi-annual renewal reminder services.
How can Yunnan's foreign trade enterprises leverage government subsidies to efficiently complete US FDA registration?
Yunnan Province's foreign trade enterprises are ushering in the best window period for exporting to the United States. With the launch of FDA international registration subsidy policies by business departments in various regions, enterprises can significantly reduce the FDA registration costs for food, medical devices, cosmetics, and pharmaceutical companies through government funding. This guide, provided by Feroza Technology, combines the latest policies with FDA compliance requirements to systematically analyze how Yunnan enterprises can complete key stages such as FDA registration, 510(k), MoCRA, and NDC at the lowest cost and highest efficiency, comprehensively enhancing their global market competitiveness.
FDA 推出化妆品不良事件实时报告仪表板，透明度大幅提升
美国 FDA 于 2025 年 9 月 12 日上线了“化妆品不良事件实时报告仪表板”（FAERS Public Dashboard for Cosmetic Products），依据 MoCRA…
FDA发布MoCRA实施指南
FDA发布《2022年化妆品监管现代化法案》（MoCRA）实施指南，要求化妆品设施注册、产品上市及严重不良事件报告。本文解析MoCRA主要内容及企业应对策略，并提供注册全流程指南，帮助企业顺利合规进入美国市场。
How can Yunnan's foreign trade enterprises leverage government subsidies to efficiently complete US FDA registration?
Yunnan Province's foreign trade enterprises are ushering in the best window period for exporting to the United States. With the launch of FDA international registration subsidy policies by business departments in various regions, enterprises can significantly reduce the FDA registration costs for food, medical devices, cosmetics, and pharmaceutical companies through government funding. This guide, provided by Feroza Technology, combines the latest policies with FDA compliance requirements to systematically analyze how Yunnan enterprises can complete key stages such as FDA registration, 510(k), MoCRA, and NDC at the lowest cost and highest efficiency, comprehensively enhancing their global market competitiveness.
2025 Annual Summary of Registration Services for Pharmaceutical and Medical Device Enterprises
2025 Company Service Summary: Provided FDA registration for 171 medical device companies and 56 pharmaceutical companies
2026财年FDA医疗器械用户费用公布，注册费和申请费全面上涨
2026财年FDA公布医疗器械用户费用（MDUFA）标准，注册费、510(k)申请费、PMA及De Novo申请费均有所上涨。小型企业可通过SBD计划申请减免。本文解析最新费用标准及企业应对策略，助力企业提前规划合规预算。
FDA 解除部分 II 类电子体温计 510(k) 预市场通知要求
美国 FDA 于 2025 年 6 月 18 日正式发布最终规则，将部分 II 类临床电子体温计设备从 510(k) 预市场通知要求中豁免，以降低监管负担、减少企业成本，并推动这类低风险设备更快进入市场。
How can Yunnan's foreign trade enterprises leverage government subsidies to efficiently complete US FDA registration?
Yunnan Province's foreign trade enterprises are ushering in the best window period for exporting to the United States. With the launch of FDA international registration subsidy policies by business departments in various regions, enterprises can significantly reduce the FDA registration costs for food, medical devices, cosmetics, and pharmaceutical companies through government funding. This guide, provided by Feroza Technology, combines the latest policies with FDA compliance requirements to systematically analyze how Yunnan enterprises can complete key stages such as FDA registration, 510(k), MoCRA, and NDC at the lowest cost and highest efficiency, comprehensively enhancing their global market competitiveness.
FDA释出“放射性电子产品上市”常见问题指南
FDA通过“放射性电子产品上市常见问题”指南，详细解答产品安全标准、报告要求、进口申报及制造合规要点，帮助企业顺利进入美国市场并确保使用者免受不必要射线风险。
How can Yunnan's foreign trade enterprises leverage government subsidies to efficiently complete US FDA registration?
Yunnan Province's foreign trade enterprises are ushering in the best window period for exporting to the United States. With the launch of FDA international registration subsidy policies by business departments in various regions, enterprises can significantly reduce the FDA registration costs for food, medical devices, cosmetics, and pharmaceutical companies through government funding. This guide, provided by Feroza Technology, combines the latest policies with FDA compliance requirements to systematically analyze how Yunnan enterprises can complete key stages such as FDA registration, 510(k), MoCRA, and NDC at the lowest cost and highest efficiency, comprehensively enhancing their global market competitiveness.
2025 Annual Summary of Registration Services for Pharmaceutical and Medical Device Enterprises
2025 Company Service Summary: Provided FDA registration for 171 medical device companies and 56 pharmaceutical companies
The FDA will fully resume normal operations.
📢 Background: Risk of US Government Shutdown Averted. Recently, the US Senate completed a series of key votes, officially passing the Continuing Appropriations and Extensions Act. ...
FDA FY 2026 Funding Lapse: Key Considerations for Companies and Industries
Background: According to the FDA's official website, if during the period between October 1, 2025, and before the FY 2026 appropriations are passed or a Continuing Resolution is passed (i.e., the “lapse period”), the FDA...
FDA监管范围全解析：食品、药品、医疗器械及化妆品注册指南
美国食品药品监督管理局（FDA）负责监管食品、药品、医疗器械、化妆品、电子产品、兽医产品和烟草制品等领域。本文将概述 FDA 的主要监管范围，并提供专业注册服务指南链接，帮助企业顺利合规进入美国市场。