各市、沈抚示范区市场监督管理局：  2024年，按照《辽宁省药品监督管理局关于在化妆品经营环节实施量化分级监管工作的通知》（辽药监妆〔2024〕21 号）（以下简称《通知》）要求，全省各级药品监管部门有序推进实施化妆品经营环节量化分级监管工作，取得较好成效，实现了监管效能和营商环境双提升。为进一步拓展推进化妆品经营环节量化分级监管工作，高标准完成2025年量化分级监管工作任务，现就有关事宜通知如下：  一、工作目标  按照《通知》要求，进一步拓展量化分级监管覆盖面，提升监管效能，压实经营者主体责任，有效规范化妆品经营秩序，保障消费者用妆安全，促进化妆品产业高质量发展。  二、实施范围  2025年重点完成对辖区内美容美发机构、宾馆洗浴场所等化妆品经营者的量化分级监管。鼓励对辖区内持有效营业执照并涵盖化妆品经营范围的化妆品经营者开展量化分级监管。  三、工作要求  （一）加强组织领导，科学有序推进量化分级监管工作。各市局要加强组织领导，结合辖区监管实际，从解决化妆品经营环节存在突出问题出发，统筹安排，明确任务、实施步骤、工作进度，科学有序推进量化分级监管工作。原则上4月底前完成对量化分级经营者的培训，11月底前完成量化分级等级评定。  （二）加强宣传培训，提高思想认识。各市局要采取多种形式进行宣传培训，积极引导执法人员和经营者正确认识量化分级监管工作的目的和意义，扎实组织经营者开展自查自纠，落实主体责任。要统一检查标准，切实提升监管效能，确保量化分级监管工作高质量开展。  （三）压实工作责任，客观评定量化分级等级。各市局要加强督导检查，压实基层工作责任，严格按《通知》规定程序对化妆品经营者开展现场检查，客观评定量化分级等级。根据化妆品经营者安全管理状况，及时动态调整量化分级评定等级。贯彻风险管理理念，将量化分级评定与日常监管、专项检查、监督抽检、不良反应监测、投诉举报等工作有机结合，引导和帮助化妆品经营者依法经营、规范经营，营造更加安全的消费环境。  （四）公平公正公开，及时张贴分级标识。现场检查结束后，及时确定量化分级等级，并按程序进行网上公示，将量化分级评定等级在经营者营业场所悬挂张贴，让消费者知晓，便于消费者做出合理消费选择，便于消费者监督。  （五）积极开拓创新，探索量化分级新方法。各市局要加强对量化分级监管工作方式方法的研究论证，不断开拓创新，进一步提升量化分级监管效能，充分发挥社会共治作用。  （六）严肃工作纪律，树立监管良好形象。各市局要加强对参与量化等级检查评定人员的思想、作风、纪律教育，文明执法，秉公用权，杜绝借检查之机吃拿卡要、不公正评定量化等级等破坏营商环境的行为，树立监管部门良好形象。  请各市局于12月10日前报送量化分级监管工作总结及相关报表。省局将适时对各市量化分级监管情况进行督导检查。

（通告 2025年第30号）按照《药品管理法》及《国家药监局关于实施新修订有关事项的公告》（2020年第47号）要求，经现场检查葵花药业集团（佳木斯）有限公司等14家企业符合《药品生产质量管理规范（2010年修订）》要求。特此通告。附件：药品GMP符合性检查企业目录（2025年 第9号）黑龙江省药品监督管理局2025年9月28日

（通告 2025年第29号）据《国家药监局 农业农村部 国家林草局 国家中医药局关于发布的公告》（2022年第22号）和《黑龙江省药品监督管理局 黑龙江省农业农村厅 黑龙江省林业和草原局 黑龙江省中医药管理局关于推动实施的通告》的要求，2025年9月9日至9月11日，我局组织对哈尔滨珍宝制药有限公司、黑龙江省松花江医药科技有限公司、黑龙江金九药业股份有限公司种植基地开展延伸检查（中药材符合性检查），结果为符合GAP要求。特此通告。附件：中药材GAP符合性延伸检查结果黑龙江省药品监督管理局2025年9月28日被检查主体被检查品种中药材品种基地建设单位基地面积（亩）基地地址经纬度坐标本次检查预计产量检查结果1.哈尔滨珍宝制药有限公司1.双黄连注射液（国药准字Z23020785）连翘山西振东道地药材开发有限公司4150亩山西省长治市平顺县东寺头乡羊老岩1.地理位置:点位1：东经113°63′08″，北纬36°17′67″；点位2：东经113°65′33″，北纬36°18′08″；点位3：东经113°66′48″，北纬36°17′77″；点位4：东经113°66′84″，北纬36°17′39″；点位5：东经113°64′88″，北纬36°16′70″；点位6：东经113°66′08″，北纬36°16′76″；点位7：东经113°64′57″，北纬36°17′23″；点位8：东经113°64′49″，北纬36°16′78″。166吨符合要求2.黑龙江省松花江医药科技有限公司2.注射用双黄连（冻干）（国药准字Z10940026）4268亩2.地理位置:点位1：东经113°62′05″，北纬36°16′74″；点位2：东经113°63′51″，北纬36°15′89″；点位3：东经113°60′33″，北纬36°13′56″；点位4：东经113°61′09″，北纬36°15′21″；点位5：东经113°61′78″，北纬36°15′74″170吨3.黑龙江金九药业股份有限公司3.双黄连注射液（国药准字Z23020813）4150亩3.地理位置:点位1：东经113°63′17″，北纬36°17′56″；点位2：东经113°64′49″，北纬36°16′78″；点位3：东经113°64′57″，北纬36°17′23″；点位4：东经113°65′23″，北纬36°16′46″；点位5：东经113°63′51″，北纬36°15′89″；点位6：东经113°62′05″，北纬36°16′77″。166吨

各药品生产（经营）企业：为推动我省中医药产业高质量发展，助力乡村全面振兴，现将2025年第五批中药饮片和中药配方颗粒新增挂网形式复核结果予以公示。一、基本情况经形式复核，符合国家或省级中药配方颗粒标准且完成生产和异地销售备案，拟增补的中药颗粒集采产品1个（见附件1）、中药饮片集采产品23个（见附件2），中药配方颗粒阳光挂网产品按照《关于做好中药配方颗粒阳光挂网采购工作的通知》要求，另行公示。按照全国中成药联盟办公室《关于取消3家企业中选资格并列入违规名单的公告》要求，山东泰尚黄精生物科技有限公司、河北燕双生药业有限公司的中选产品取消挂网资格。二、公示要求（一）公示期：2025年9月30日至10月10日。（二）申诉质疑提交截止时间为2025年10月10日18时。（三）所有申诉质疑材料制作成1个PDF文件（命名为“申诉质疑企业名称+药品名称+规格”）上传到指定邮箱（gansuzyyp@163.com），未按规定上传材料的不予受理，造成企业损失的自行承担后果。业务咨询电话：0931-2909261、2909381政策咨询电话：0931-8127072（省医保局）附件：1.2025年第五批中药配方颗粒集采未中选产品价格联动公示表2.2025年第五批中药饮片集采未中选产品价格联动结果公示表甘肃省公共资源交易中心2025年9月29日

根据《中华人民共和国行政许可法》第七十条和《药品生产监督管理办法》（国家市场监督管理总局令第28号）第二十条之规定，依企业申请，经我局研究决定，依法注销河北欣瑞未来科技有限公司的《药品生产许可证》。 特此公告。附件：《药品生产许可证》注销名单(共计1家）河北省药品监督管理局2025年9月29日序号企业名称许可证编号社会信用代码法定代表人企业负责人质量负责人生产地址和生产范围注销原因1河北欣瑞未来科技有限公司冀2021000791130101MA0GDF8K8H高雪松高雪松赵阳受托方是河南润弘制药股份有限公司，生产地址是河南省新郑市庆安路227号，受托产品为氨基己酸注射液（暂无批准文号;规格20ml：5g）,卡络磺钠注射液（暂无批准文号;规格5ml：25mg）***企业申请

贝克曼库尔特实验系统（苏州）有限公司报告，由于DXI 800分析仪中的取放装置机架，可能因机架配件中的子部件物理干扰，出现运动错误，导致仪器进入“未就绪”或“已暂停”状态的情况，贝克曼库尔特实验系统（苏州）有限公司对其生产的全自动化学发光免疫分析仪主动召回。召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。

根据《中华人民共和国行政许可法》第七十条和《医疗器械监督管理条例》第六十六条的相关规定，按照《浙江省食品药品监督管理局办公室关于发布第二类医疗器械注册证书补办程序等5个相关工作程序的通知》（浙食药监规[2016]3号）的具体要求，依企业申请，现注销维灵（杭州）信息技术有限公司“一次性使用心电电极”的医疗器械注册证书（注册证编号：浙械注准20222071076）。特此通告。联系电话：0571-88903347联系地址：杭州市莫干山路文北巷27号邮编：3100122025年9月30日

依据《中华人民共和国行政许可法》第七十条、《执业药师注册管理办法》第二十四条的规定，现依法注销向兴玉等24人的《执业药师注册证》，并予以公告。　　附件：注销的注册证内容                                                             　　　　　　　　　　　　　　　　　　　　　　　　　　 重庆市药品监督管理局                                　　　　　　　　　　　　　　　　　　　　　　　　　2025年9月25日 序号姓名性别执业单位《执业药师注册证》编号1向兴玉女巫山县桐君阁十八大药房5012223700412张前华男巫山县元济堂大药房5022223700423张天福男巫山县佳康大药房5022203701244武军男巫山县远康大药房5012193700255方璐女巫山县林丹大药房5012233700106谌德金男巫山县麦克红康杏林大药房5012243700787罗川男巫山县陈兵权大药房502221370024l8谢素娟女重庆薇婷大药房5022213700019何长军男巫山县好药师佳康大药房50222237000910杨超男重庆市张地威大药房（个人独资）50222537009611史发根男巫山县金伍壹科大药房50222437003012王元雄男巫山县泰昌大药房50122437002813赵本甲男巫山县嘉荣大药房有限公司50122437004414胡成富男巫山县飞凤大药房50122437004715马畔存女重庆市万和药品医药有限公司平湖路二店50222337003716孙友敏女巫山县桐君阁大药房巫峡五十九店50121937013517刘莉女巫山县黎杨凡大药房50122537008318危永胜男巫山县五一大药房50222437004019汪佑清女重庆金康源大药房有限责任公司50222237004720成荣女巫山县抱龙五心大药房50222437001021谭杨平男巫山县五一大药房官渡店50221937010722王长春女巫山县振生大药房50222337001923江艳艳女巫山县五心好药师陈杰大药房(个人独资）50222437012824何华臣女巫山县骡坪五心大药房502224370141

经广元市食品药品检验检测中心等9家药品检验机构检验，标示为山西力玖药业有限公司等15家药品生产企业生产的16批次药品不符合规定。现将相关情况通告如下：一、经广元市食品药品检验检测中心检验，标示为山西力玖药业有限公司生产的1批次硫酸亚铁片不符合规定，不符合规定项目为检查（溶出度）。经南充市食品药品检验所检验，标示为山西国润制药有限公司生产的1批次三合钙咀嚼片不符合规定，不符合规定项目为检查（重量差异）。经内江市食品药品检验检测中心检验，标示为四川德元药业集团有限公司生产的1批次冰胆搽剂不符合规定，不符合规定项目为检查（乙醇量）。经成都市药品检验研究院检验，标示为四川厚生天佐药业有限公司生产的1批次消肿镇痛膏不符合规定，不符合规定项目为检查（黏附性）。经乐山市食品药品检验检测中心检验，标示为四川宏康源药业有限公司生产的1批次降香不符合规定，不符合规定项目为性状、鉴别（薄层色谱（2）（3））。经成都市药品检验研究院检验，标示为四川省祥云中药饮片进出口有限公司生产的1批次灯盏细辛（灯盏花）不符合规定，不符合规定项目为性状。经南充市食品药品检验所检验，标示为四川君子兰药业有限公司生产的1批次炙甘草不符合规定，不符合规定项目为含量测定（甘草苷）。经广元市食品药品检验检测中心检验，标示为南城县建洪中药饮片厂生产的1批次蝉蜕不符合规定，不符合规定项目为性状。经遂宁市检验检测中心检验，标示为森科药业（成都）有限公司生产的1批次蝉蜕不符合规定，不符合规定项目为性状。经广元市食品药品检验检测中心检验，标示为四川光然中药材饮片有限公司生产的1批次款冬花（蜜款冬花）不符合规定，不符合规定项目为检查（药屑及杂质）。经广元市食品药品检验检测中心检验，标示为湖南省国卓中药饮片有限公司生产的1批次淫羊藿不符合规定，不符合规定项目为检查（药屑及杂质）、含量测定（总黄酮醇苷）。经宜宾市检验检测中心检验，标示为邵阳神农中药科技发展有限公司生产的1批次人参（人参片）不符合规定，不符合规定项目为性状、检查（（水分）（其他有机氯类农药残留量））、含量测定（（人参皂苷Rg1和人参皂苷Re的总量）（人参皂苷Rb1））。经成都市药品检验研究院检验，标示为四川五盛药业集团有限责任公司生产的1批次山楂（净山楂）不符合规定，不符合规定项目为检查（水分）。经巴中市产品质量检验检测中心检验，标示为成都仁济宏药业有限公司生产的1批次土鳖虫不符合规定，不符合规定项目为性状、检查（杂质）。经达州市食品药品检验所检验，标示为四川光然中药材饮片有限公司生产的1批次五加皮不符合规定，不符合规定项目为检查（总灰分）。经巴中市产品质量检验检测中心检验，标示为成都市明德药业有限公司生产的1批次款冬花（蜜款冬花）不符合规定，不符合规定项目为性状、检查（杂质）。二、对上述不符合规定药品，药品监督管理部门已要求相关企业和单位采取暂停销售使用、召回等风险控制措施，对不符合规定原因开展调查并切实进行整改。三、四川省药品监督管理局要求相关药品监督管理部门依据《中华人民共和国药品管理法》，组织对上述企业和单位生产销售假劣药品的违法行为立案调查，并按规定公开查处结果。特此通告。附件：16批次不符合规定药品名单 四川省药品监督管理局2025年9月30日序号药品品名标示药品上市许可持有人标示生产企业名称药品规格生产批号检品来源检验依据检验结果不符合规定项目检验机构名称备注1硫酸亚铁片山西力玖药业有限公司山西力玖药业有限公司0.3克（以铁计60毫克）20221004广旺矿区代池坝医院《中国药典》2020年版二部、四部不符合规定[检查]（溶出度）广元市食品药品检验检测中心企业留样经山西省检验检测中心检验符合规定。2三合钙咀嚼片/山西国润制药有限公司每片含乳酸钙、葡萄糖酸钙、磷酸氢钙各0.05克240601四川泽仁堂药业有限责任公司国家药品监督管理局国家药品标准WS-10001-（HD-0205）-2002及《中国药典》2020年版四部不符合规定[检查]（重量差异）南充市食品药品检验所 /3冰胆搽剂/四川德元药业集团有限公司每支装10ml250401四川德元药业集团有限公司国家食品药品监督管理总局国家药品标准WS-5615（B-0615）-2014Z不符合规定[检查]（乙醇量）内江市食品药品检验检测中心/4消肿镇痛膏/四川厚生天佐药业有限公司每片8厘米×12厘米241102成都市龙泉驿区第一人民医院国家药品监督管理局国家药品标准WS-10920（ZD-0920）-2002-2011Z -2018不符合规定[检查]（黏附性）成都市药品检验研究院/5降香/四川宏康源药业有限公司中药饮片230301夹江县中医医院《中国药典》2020年版一部不符合规定[性状][鉴别]（薄层色谱（2）（3））乐山市食品药品检验检测中心/6灯盏细辛（灯盏花）/四川省祥云中药饮片进出口有限公司中药饮片240501四川省祥云中药饮片进出口有限公司《中国药典》2020年版一部及四部不符合规定[性状]成都市药品检验研究院/7炙甘草/四川君子兰药业有限公司中药饮片230401南充市顺庆区李家镇中心卫生院《中国药典》2020年版一部不符合规定[含量测定]（甘草苷）南充市食品药品检验所/8蝉蜕/南城县建洪中药饮片厂中药饮片2504026攀枝花市仁源堂中药馆《中国药典》2020年版一部、四部不符合规定[性状]广元市食品药品检验检测中心/9蝉蜕/森科药业（成都）有限公司中药饮片240308遂宁市安居区三家镇中心卫生院《中国药典》2020年版一部不符合规定[性状]遂宁市检验检测中心/10款冬花（蜜款冬花）/四川光然中药材饮片有限公司中药饮片221208苍溪县百姓老年病专科医院有限公司《中国药典》2020年版一部、四部不符合规定[检查]（药屑及杂质）广元市食品药品检验检测中心/11淫羊藿/湖南省国卓中药饮片有限公司中药饮片240901旺苍县苟芳大药房《中国药典》2020年版一部、四部不符合规定[检查]（药屑及杂质）[含量测定]（总黄酮醇苷）广元市食品药品检验检测中心/12人参（人参片）/邵阳神农中药科技发展有限公司中药饮片230401宜宾康和大药房有限公司滨江连锁店《中国药典》2020年版一部不符合规定[性状][检查]（（水分）（其他有机氯类农药残留量））[含量测定]（（人参皂苷Rg1和人参皂苷Re的总量）（人参皂苷Rb1））宜宾市检验检测中心/13山楂（净山楂）/四川五盛药业集团有限责任公司中药饮片250401四川五盛药业集团有限责任公司《中国药典》2020年版一部、四部及国家药品监督管理局国家中药饮片炮制规范YBZ-PG-0005A-2022不符合规定[检查]（水分）成都市药品检验研究院/14土鳖虫/成都仁济宏药业有限公司中药饮片240901巴中市恩阳区柳林镇卫生院《中国药典》2020年版第一增补本不符合规定[性状][检查]（杂质）巴中市产品质量检验检测中心/15五加皮/四川光然中药材饮片有限公司中药饮片250301四川新天地药业有限责任公司《中国药典》2020年版一部不符合规定[检查]（总灰分）达州市食品药品检验所/16款冬花（蜜款冬花）/成都市明德药业有限公司中药饮片24040101巴中市巴州区曾口中心卫生院《中国药典》2020年版一部、四部不符合规定[性状][检查]（杂质）巴中市产品质量检验检测中心/

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:25-HFD-45-09-03Product:DrugsRecipient:Pamela K. Den Besten, DDS, MS521 Parnassus AvenueRoom S612, Box 0422San Francisco,CA94022-0422United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERDear Dr. Den Besten:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between September 16 and October 15, 2024. Investigator Dustin R. Abaonza, representing FDA, reviewed your conduct as the sponsor-investigator of a clinical investigation (Protocol 15-18297, “Pilot Study: Oral Microbiome and Dental Plaque Control with Livionex® Dental Gel in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)”) of the investigational drug Livionex® Dental Gel.This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, Investigator Abaonza presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your November 5, 2024, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated November 5, 2024, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:You failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].FDA regulations require a sponsor to submit, and to have in effect, an IND before initiating a clinical investigation of a drug that is subject to 21 CFR 312.2(a) [see 21 CFR 312.20 and 312.40(a)] in human subjects, unless the clinical investigation qualifies for an IND exemption under 21 CFR 312.2. You failed to comply with these requirements. Specifically, you conducted Protocol 15-18297, a clinical investigation of the investigational drug Livionex® Dental Gel (Livionex) subject to section 505 of the FD&C Act [21 U.S.C. 355], without submitting and having in effect an IND.Section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] defines drug, in part, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease….” You studied the efficacy of Livionex to mitigate, cure, treat, or prevent gingivitis and dental caries. As shown by the protocol, the primary and secondary objectives of Protocol 15-18297 were to evaluate the efficacy of Livionex in plaque and gingivitis reduction in pediatric hematopoietic stem cell transplantation (HSCT) recipients. To assess the efficacy of Livionex, Protocol 15-18297 used various dental parameters, which were also identified as the study efficacy endpoints. These efficacy-related assessments included the change in dental plaque scores and gingival inflammation scores from Day 0 to 7, and Day 44 ±14 days, for each subject, as well as the comparison of plaque scores and gingival inflammation between the test and control groups. In addition, optical coherence tomography was used to image and quantify plaque presence. Plaque staining assessments were also performed, and standardized photographs were taken for plaque distribution mapping. Therefore, Protocol 15-18297 collected study data to assess the effect of Livionex on improving plaque control and gingivitis prevention in pediatric subjects undergoing HSCT.Based on the study design of Protocol 15-18297, the investigational product, Livionex® Dental Gel, as used in the clinical investigation was a drug as defined in section 201(g)(1) of the FD&C Act, because Livionex was studied for use in the treatment of gingivitis and dental caries. Thus, before initiating the clinical investigation of Livionex under Protocol 15-18297, under 21 CFR 312.40, you were required to submit an IND to FDA and to have an IND in effect. FDA’s records indicate that you failed to submit an IND before conducting Protocol 15-18297, in which 43 subjects were enrolled and received study drug between September 2016 and January 2020, under your oversight as the sponsor-investigator.We acknowledge that this finding was not included on the Form FDA 483 you received. However, this finding was discussed with you during the inspection, and your written response does in part address this finding.In your November 5, 2024, written response to the Form FDA 483, you explained that in 2016 the initial principal investigator had consulted with the University of California, San Francisco’s Office of Ethics and Compliance regarding the IND requirements related to the study and had represented that Livionex was an over-the-counter (OTC) toothpaste. In response, the Office of Ethics and Compliance instructed the previous principal investigator to include rationale in the IRB application, confirming that the study meets each of the IND exemption criteria. We note that the rationale for exemption included in the IRB application for this study incorrectly stated that Livionex is an OTC toothpaste, which is lawfully marketed in the United States and does not require FDA approval for its use.You stated in your written response that it was your understanding at the time that all products used in this study were lawfully marketed, and that the study met all IND exemption criteria. You also stated there was no intention that the study outcomes would be used to support any change or any marketing claims by any toothpaste manufacturers, and as such, this study was not conducted as a clinical trial seeking regulatory approval from the FDA.As noted above, FDA regulations require a sponsor to submit an IND before conducting a clinical investigation of a drug in human subjects, unless the clinical investigation qualifies for an IND exemption under 21 CFR 312.2(b). Under 21 CFR 312.2(b)(1), the clinical investigation of alawfully marketed drug productin the United States is exempt from the IND regulations for a clinical investigation if all the exemption criteria in 21 CFR 312.2(b)(1) are met.The clinical investigation of Liovionex Dental Gel conducted under Protocol 15-18297 does not qualify for an IND exemption under 312.2(b)(1) because Livionex is not lawfully marketed as a drug product in the United States. Specifically, Livionex is not the subject of a new drug or abbreviated new drug application approved under section 505 of the FD&C Act [21 U.S.C. 355]. Additionally, Livionex does not contain an active ingredient that is a part of any OTC monograph.In your written response, you also stated that this FDA inspection had been a learning process, and you are much better informed as to the correct procedures, protocols, and monitoring of any future IND regulated clinical trials. You noted that you and your team have completed training on FDA regulatory requirements and reached out the Office of Ethics and Compliance for additional targeted education. You further stated that you will review internal procedures and resources regarding investigational drug and device determinations to ensure compliance with regulatory standards.While we acknowledge the corrective and preventive actions you have taken or plan to take, your response is inadequate because you did not include sufficient information about how you will determine whether IND regulations apply to future clinical investigations of products regulated by FDA, as required by 21 CFR 312.2(a). Without these details, we are unable to determine whether your corrective action plan is adequate to prevent similar violations in the future.As a sponsor-investigator, you have ultimate oversight of the clinical investigation and are responsible for compliance with all applicable FDA regulations governing the conduct of clinical investigations and the protection of human subjects, including submitting and having in effect an IND before initiating a clinical investigation. Your failure to submit, and to have in effect, an IND before initiating Protocol 15-18297 with an investigational drug raises significant concerns about the safety and welfare of enrolled subjects and raises concerns about the validity and integrity of the data collected during the conduct of this clinical investigation.This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Should you have any questions or concerns regarding this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to:Brittany L. Garr, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely yours,/S/David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration