For Immediate Release: September 22, 2023      Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, the FDA issued the revised, draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products . This draft guidance outlines the recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of drug or biological drug products.  This draft guidance replaces the draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products issued on December 29, 2017. On Wednesday, the FDA  provided an update on its work to advance its strategy to help prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. The update noted significant actions that have been taken to advance the goals of the strategy which can be found on the prevention strategy webpage . On Wednesday, the FDA provided an update on its work to advance its strategy to help prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. The update noted significant actions that have been taken to advance the goals of the strategy which can be found on the prevention strategy webpage . On Tuesday, the FDA announced that the Accreditation Scheme for Conformity Assessment (ASCA) program is converting from a pilot to a permanent program. This transition is authorized by the Medical Device User Fee Amendments of 2022 (MDUFA V). ASCA is a voluntary accreditation program that capitalizes on the increasingly prominent role of consensus standards in regulatory science. The ASCA program’s goals are to streamline conformity assessment in medical device submissions, enhance the FDA’s confidence in test methods and results, decrease the need for additional information related to conformance with a standard, and promote consistency, predictability and efficiency in medical device review. On Tuesday, the FDA issued the draft Center for Devices and Radiological Health International Harmonization Strategic Plan . This plan includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on the work CDRH is currently doing with international stakeholders. As the design, manufacture, distribution and use of medical devices have become increasingly complex and global, the need for harmonized approaches and reliance among regulatory authorities has become more vital. You can read the CDRH Statement here . On Tuesday, the FDA issued the draft Center for Devices and Radiological Health International Harmonization Strategic Plan . This plan includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on the work CDRH is currently doing with international stakeholders. As the design, manufacture, distribution and use of medical devices have become increasingly complex and global, the need for harmonized approaches and reliance among regulatory authorities has become more vital. You can read the CDRH Statement here . The FDA Office of Women’s Health (OWH) works to protect, promote, and advance the health of women through research, education, and outreach. In collaboration with the Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP), OWH will host a free public workshop on October 11, 2023, Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research . The workshop will include presentations and session discussions by experts in the fields of clinical pharmacology, obstetrics and gynecology, endocrinology, and clinical care. Speakers will discuss the current understanding of the impact of menopause on the pharmacokinetics and pharmacodynamics (the movement of drugs through the body, and the body’s biological response to drugs, respectively), and exposure-response relationships of FDA-regulated drugs and biological products used by menopausal women for non-menopause-related indications. Researchers, educators, clinicians, and patients may benefit from attending this scientific workshop, which will be held virtually. To receive a link to attend, please register in advance . The FDA Office of Women^s Health (OWH) works to protect, promote, and advance the health of women through research, education, and outreach. In collaboration with the Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP), OWH will host a free public workshop on October 11, 2023, Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research . The workshop will include presentations and session discussions by experts in the fields of clinical pharmacology, obstetrics and gynecology, endocrinology, and clinical care. Speakers will discuss the current understanding of the impact of menopause on the pharmacokinetics and pharmacodynamics (the movement of drugs through the body, and the body^s biological response to drugs, respectively), and exposure-response relationships of FDA-regulated drugs and biological products used by menopausal women for non-menopause-related indications. Researchers, educators, clinicians, and patients may benefit from attending this scientific workshop, which will be held virtually. To receive a link to attend, please register in advance . Related Information FDA Newsroom ### The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.    Inquiries    Media:    FDA Office of Media Affairs     888-INFO-FDA                    Consumer:  888-INFO-FDA      Inquiries    Media:    FDA Office of Media Affairs     888-INFO-FDA                    Consumer:  888-INFO-FDA



For Immediate Release:
September 22, 2023




FDA Roundup: September 22, 2023

美国食品药品监督管理局综述：2023 年 9 月 22 日

For Immediate Release: September 22, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Thursday, the FDA issued the revised, draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products . This draft guidance outlines the recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of drug or biological drug products.  This draft guidance replaces the draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products issued on December 29, 2017.

On Wednesday, the FDA  provided an update on its work to advance its strategy to help prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. The update noted significant actions that have been taken to advance the goals of the strategy which can be found on the prevention strategy webpage .

On Tuesday, the FDA announced that the Accreditation Scheme for Conformity Assessment (ASCA) program is converting from a pilot to a permanent program. This transition is authorized by the Medical Device User Fee Amendments of 2022 (MDUFA V). ASCA is a voluntary accreditation program that capitalizes on the increasingly prominent role of consensus standards in regulatory science. The ASCA program`s goals are to streamline conformity assessment in medical device submissions, enhance the FDA`s confidence in test methods and results, decrease the need for additional information related to conformance with a standard, and promote consistency, predictability and efficiency in medical device review.

On Tuesday, the FDA issued the draft Center for Devices and Radiological Health International Harmonization Strategic Plan . This plan includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on the work CDRH is currently doing with international stakeholders. As the design, manufacture, distribution and use of medical devices have become increasingly complex and global, the need for harmonized approaches and reliance among regulatory authorities has become more vital. You can read the CDRH Statement here .

The FDA Office of Women`s Health (OWH) works to protect, promote, and advance the health of women through research, education, and outreach. In collaboration with the Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP), OWH will host a free public workshop on October 11, 2023, Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research . The workshop will include presentations and session discussions by experts in the fields of clinical pharmacology, obstetrics and gynecology, endocrinology, and clinical care. Speakers will discuss the current understanding of the impact of menopause on the pharmacokinetics and pharmacodynamics (the movement of drugs through the body, and the body`s biological response to drugs, respectively), and exposure-response relationships of FDA-regulated drugs and biological products used by menopausal women for non-menopause-related indications. Researchers, educators, clinicians, and patients may benefit from attending this scientific workshop, which will be held virtually. To receive a link to attend, please register in advance .

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation`s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Inquiries    Media:    FDA Office of Media Affairs     888-INFO-FDA                    Consumer:  888-INFO-FDA

今天,美国食品和药物管理局(FDA)提供了来自该机构各地的新闻摘要:

周四,美国食品药品监督管理局发布了修订后的指南草案 美国食品药品监督管理局与PDUFA产品的赞助商或申请人之间的正式会议 。该指南草案概述了就美国食品药品监督管理局与申办者或申请人之间就药品或生物药品的开发和审查举行的正式会议向业界提出的建议。 本指南草案取代了2017年12月29日发布的`PDUFA产品的美国食品药品监督管理局与赞助商或申请人之间的正式会议`指南草案。

周三,美国食品药品监督管理局提供了其工作的最新情况,以推进其战略,以帮助预防与食用婴儿配方奶粉相关的阪崎克罗诺杆菌疾病。更新指出了为推进战略目标而采取的重大行动,这些行动可以在预防战略网页上找到。

周二,美国食品药品监督管理局宣布合格评定认可计划(ASCA)计划正在从试点转变为永久性计划。此过渡由 2022 年医疗器械用户费用修正案 (医疗器械UFA V) 授权。ASCA是一项自愿认证计划,它利用了共识标准在监管科学中日益突出的作用。ASCA计划的目标是简化医疗器械提交的合格评定,增强美国食品药品监督管理局对测试方法和结果的信心,减少对与标准符合性相关的额外信息的需求,并提高医疗器械审查的一致性、可预测性和效率。

周二,美国食品药品监督管理局发布了设备和放射健康中心国际协调战略计划草案。该计划包括直接鼓励医疗器械监管机构之间的协调、融合和依赖的具体战略(如适用),并以CDRH目前与国际利益相关者所做的工作为基础。随着医疗器械的设计、制造、分销和使用变得越来越复杂和全球化,监管机构之间对统一方法和依赖的需求变得更加重要。您可以在此处阅读CDRH声明。

美国食品药品监督管理局妇女健康办公室 (OWH) 致力于通过研究、教育和外展来保护、促进和促进妇女的健康。OWH将与药物评估和研究中心(CDER)临床药理学办公室(OCP)合作,于2023年10月11日举办免费的公开研讨会,更年期:对临床药理学的潜在影响和未来研究的机会。研讨会将包括临床药理学、妇产科、内分泌学和临床护理领域的专家的演讲和会议讨论。演讲者将讨论目前对更年期对药代动力学和药效学(药物在体内的运动和身体对药物的生物反应)的影响的理解,以及更年期妇女用于非更年期相关适应症的美国食品药品监督管理局管制药物和生物制品的暴露反应关系。研究人员、教育工作者、临床医生和患者可能会从参加这个虚拟举行的科学研讨会中受益。要获得参加链接,请提前注册。

美国食品药品监督管理局 新闻编辑室

该美国食品药品监督管理局是美国卫生与公众服务部下属的一个机构,通过确保人类和兽药、疫苗和其他供人使用的生物制品以及医疗设备的安全性、有效性和安全性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、散发电子辐射的产品的安全和保障,并负责监管烟草制品。

查询媒体:美国食品药品监督管理局媒体事务办公室 888-INFO-美国食品药品监督管理局 消费者:888-INFO-美国食品药品监督管理局

Information destinée aux établissements de santé et aux centres de radiologie                           Cette action de sécurité est enregistrée à l’ANSM sous le n° R2319287. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Philips Medical Systems.Les utilisateurs concernés ont reçu le courrier ci-joint.                                    Téléchargez le courrier de la société Philips Medical Systems (18/09/2023)                                             Téléchargez le courrier de la société Philips Medical Systems (18/09/2023)

Information for health institutions and radiology centers This safety action is registered with the ANSM under No. R2319287. If you have any questions, please contact the issuer of the security action directly. The ANSM has been informed of the implementation of a security action carried out by the company Philips Medical Systems.The users concerned have received the attached letter.                                    Download the letter from Philips Medical Systems (18/09/2023) Download the letter from Philips Medical Systems (18/09/2023)

Information destinée aux établissements de santé et aux centres de radiologie

Information for healthcare facilities and radiology centres

Appareil de radiologie - RX – Essenta DR Compact – Philips Medical Systems

X-ray machine - RX – Essenta DR Compact – Philips Medical Systems

X 光机 - RX – 益升达 DR 紧凑型 – 飞利浦医疗系统

Cette action de sécurité est enregistrée à l`ANSM sous le n° R2319287. Pour toute question, merci de vous adresser directement à l`émetteur de l`action de sécurité.L`ANSM a été informée de la mise en œuvre d`une action de sécurité effectuée par la société Philips Medical Systems.Les utilisateurs concernés ont reçu le courrier ci-joint.

Téléchargez le courrier de la société Philips Medical Systems (18/09/2023)

This security action is registered at l`ANSM under the number R2319287. If you have any questions, please contact the `issuer of the `security action. L`ANSM has been informed of the implementation of `a security action carried out by the company Philips Medical Systems.The users concerned have received the attached letter.

Download the letter from Philips Medical Systems (18/09/2023)

此安全操作在法国国家药品和保健品安全检测局中注册,编号为 R2319287。如果您有任何疑问,请直接联系安全操作的颁发者。法国国家药品和保健品安全检测局已被告知飞利浦医疗系统公司已实施安全措施。有关用户已收到所附信函。

下载飞利浦医疗系统的信函 (18/09/2023)

为规范人工智能医疗器械相关产品的管理，国家药监局器审中心组织制定了《磁共振成像系统人工智能软件功能审评要点》，现予发布。 　　特此通告。 　　附件：磁共振成像系统人工智能软件功能审评要点（下载） 　　附件：磁共振成像系统人工智能软件功能审评要点（下载） 国家药品监督管理局    医疗器械技术审评中心  2023年9月15日

　　为规范人工智能医疗器械相关产品的管理，国家药监局器审中心组织制定了《磁共振成像系统人工智能软件功能审评要点》，现予发布。

国家药监局器审中心关于发布磁共振成像系统人工智能软件功能审评要点的通告（2023年第36号）

为规范人工智能医疗器械相关产品的管理,国家药监局器审中心组织制定了《磁共振成像系统人工智能软件功能审评要点》,现予发布。

附件:磁共振成像系统人工智能软件功能审评要点(下载)

2023年8月,国家药监局共批准注册医疗器械产品288个。其中,境内第三类医疗器械产品229个,进口第三类医疗器械产品33个,进口第二类医疗器械产品24个,港澳台医疗器械产品2个(具体产品见附件)。  特此公告。    附件:2023年8月批准注册医疗器械产品目录      国家药监局  2023年9月14日国家药品监督管理局2023年第122号公告附件.docx国家药监局关于批准注册288个医疗器械产品的公告(2023年8月)(2023年第122号)

国家药监局关于批准注册288个医疗器械产品的公告(2023年8月)(2023年第122号)

2023年8月,国家药监局共批准注册医疗器械产品288个。其中,境内第三类医疗器械产品229个,进口第三类医疗器械产品33个,进口第二类医疗器械产品24个,港澳台医疗器械产品2个(具体产品见附件)。

附件:2023年8月批准注册医疗器械产品目录

国家药品监督管理局2023年第122号公告附件.docx

"Medtronic Inc., a subsidiary of Medtronic plc, is initiating a voluntary recall of electrode delivery sheaths (National Medical Products Administration registration number: 20173142128) due to an error in the printed expiration date on specific models and batches of finished product labels. The recall has been classified as a Level II recall."

美敦力(上海)管理有限公司报告,由于特定型号特定批次地垫成品标签上打印的失效日期错误,生产商美敦力公司Medtronic Inc.对电极传送鞘管(国械注进20173142128)主动召回。召回级别为二级召回。

美敦力(上海)管理有限公司报告,由于特定型号特定批次地垫成品标签上打印的失效日期错误,生产商美敦力公司Medtronic Inc.对电极传送鞘管(国械注进20173142128)主动召回。召回级别为二级召回。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》。    附件:医疗器械召回事件报告表                                                      2023年9月15日美敦力(上海)管理有限公司召回报表.pdf美敦力公司Medtronic Inc.对电极传送鞘管主动召回

美敦力公司Medtronic Inc.对电极传送鞘管主动召回

美敦力(上海)管理有限公司报告,由于特定型号特定批次地垫成品标签上打印的失效日期错误,生产商美敦力公司Medtronic Inc.对电极传送鞘管(国械注进20173142128)主动召回。召回级别为二级召回。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》。

美敦力(上海)管理有限公司召回报表.pdf

"Medtronic Inc., a subsidiary of Medtronic plc, is initiating a voluntary recall of the Spinal Cord Stimulator Clinician Programmer System (National Medical Products Administration registration number: 20202120339), Patient Programmer (National Medical Products Administration registration number: 20232120219), and Neurostimulation Device Programmer (National Medical Products Administration registration number: 20192120588) due to an incompatibility issue between the updated A710 CP application (v2.0.136) and the existing A901 Communication Manager application (v1.0.1169), which has resulted in the inability of the A710 CP application to communicate with Implantable Neurostimulators (INS) and Wireless External Neurostimulators (WENS). The recall has been classified as a Level II recall."

美敦力(上海)管理有限公司报告,由于更新后的A710 CP应用程序(v2.0.136)和现有A901通信管理器应用程序(v1.0.1169)之间不兼容,从而导致A710 CP应用程序无法与植入式神经刺激器(INS)/无线体外神经刺激器(WENS)通信。生产商美敦力公司Medtronic Inc.对脊髓神经刺激器医生程控系统(国械注进20202120339)、患者程控仪(国械注进20232120219)、神经调控设备程控仪(国械注进20192120588)主动召回。召回级别为二级召回。

美敦力(上海)管理有限公司报告,由于更新后的A710 CP应用程序(v2.0.136)和现有A901通信管理器应用程序(v1.0.1169)之间不兼容,从而导致A710 CP应用程序无法与植入式神经刺激器(INS)/无线体外神经刺激器(WENS)通信。生产商美敦力公司Medtronic Inc.对脊髓神经刺激器医生程控系统(国械注进20202120339)、患者程控仪(国械注进20232120219)、神经调控设备程控仪(国械注进20192120588)主动召回。召回级别为二级召回。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》。    附件:医疗器械召回事件报告表                                                      2023年9月15日美敦力(上海)管理有限公司召回 报表.pdf美敦力公司Medtronic Inc.对神经调控设备程控仪、脊髓神经刺激器医生程控系统、患者程控仪主动召回

Medtronic Inc., a subsidiary of Medtronic plc, is initiating a voluntary recall of the Neurostimulation Device Programmer, Spinal Cord Stimulator Clinician Programmer System, and Patient Programmer.

美敦力公司Medtronic Inc.对神经调控设备程控仪、脊髓神经刺激器医生程控系统、患者程控仪主动召回

美敦力(上海)管理有限公司报告,由于更新后的A710 CP应用程序(v2.0.136)和现有A901通信管理器应用程序(v1.0.1169)之间不兼容,从而导致A710 CP应用程序无法与植入式神经刺激器(INS)/无线体外神经刺激器(WENS)通信。生产商美敦力公司Medtronic Inc.对脊髓神经刺激器医生程控系统(国械注进20202120339)、患者程控仪(国械注进20232120219)、神经调控设备程控仪(国械注进20192120588)主动召回。召回级别为二级召回。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》。

美敦力(上海)管理有限公司召回 报表.pdf

For Immediate Release: September 15, 2023      Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA issued the draft guidance “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” and corresponding Notice of Availability (NOA). In this draft guidance, the FDA outlines its recommendations for biosimilar and interchangeable biosimilar product labeling. The FDA has now approved 42 biosimilar products, including four interchangeable biosimilars, and has gained valuable experience about labeling considerations for biosimilar and interchangeable biosimilar products. This guidance considers that experience and includes recommendations on labeling for interchangeable biosimilar products and other topics. For information on how to submit comments, please visit https://www.regulations.gov/docket/FDA-2016-D-0643 Today, the FDA issued the draft guidance ^ Labeling for Biosimilar and Interchangeable Biosimilar Products ^ and corresponding Notice of Availability (NOA). In this draft guidance, the FDA outlines its recommendations for biosimilar and interchangeable biosimilar product labeling. The FDA has now approved 42 biosimilar products, including four interchangeable biosimilars, and has gained valuable experience about labeling considerations for biosimilar and interchangeable biosimilar products. This guidance considers that experience and includes recommendations on labeling for interchangeable biosimilar products and other topics. For information on how to submit comments, please visit https://www.regulations.gov/docket/FDA-2016-D-0643 Today, the FDA issued the draft guidance ^ Labeling for Biosimilar and Interchangeable Biosimilar Products ^ and corresponding Notice of Availability (NOA). In this draft guidance, the FDA outlines its recommendations for biosimilar and interchangeable biosimilar product labeling. The FDA has now approved 42 biosimilar products, including four interchangeable biosimilars, and has gained valuable experience about labeling considerations for biosimilar and interchangeable biosimilar products. This guidance considers that experience and includes recommendations on labeling for interchangeable biosimilar products and other topics. For information on how to submit comments, please visit https://www.regulations.gov/docket/FDA-2016-D-0643 On Thursday, the FDA issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech. These products were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped the FDA to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers. On Thursday, the FDA reminded consumers in It’s a Good Time to Get Your Flu Vaccine that FDA-approved flu vaccines prevent influenza and provide important benefits. Getting vaccinated in the fall can lower your chances of getting the flu. Haven’t had your flu shot yet? It’s not too late. Every flu season is different. Your best defense against the flu is to get a vaccine every year. On Thursday, the FDA issued an update to the final guidance: Breakthrough Devices Program . The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities. The FDA has also updated the Breakthrough Devices Program website to update the device designations data and the marketing authorizations list with information from April 1 to June 30, 2023 . On Thursday, the FDA issued an update to the final guidance: Breakthrough Devices Program . The updates align with the actions outlined in the FDA^s Center for Devices and Radiological Health Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities. The FDA has also updated the Breakthrough Devices Program website to update the device designations data and the marketing authorizations list with information from April 1 to June 30, 2023 . On Thursday, the FDA issued an alert to parents and caregivers about LittleOak infant formulas that are currently being voluntarily recalled by the company. The products have been sold in the U.S. illegally because the company has not submitted the required premarket notification. Premarket notifications for new infant formula are intended to demonstrate the safety and nutritional adequacy of the formula by providing the FDA the opportunity to review key information about ingredients in the product, key nutritional information, and manufacturing information, among other things, before the product is available long-term on the U.S. market. It is prohibited to introduce into U.S. commerce a new infant formula without submitting a premarket notification to the FDA. The FDA also expressed concerns that preparation instructions on the label of the LittleOak infant formula containers do not align with measurements commonly displayed on infant formula bottles in the U.S., which may pose challenges to caregivers and impede their ability to properly mix the formula at the appropriate concentration. On Thursday, the FDA approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda). Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation, and evaluation of evidence for independent FDA review. Project Renewal is intended to keep older, commonly prescribed oncology drugs’ labeling up-to-date, while providing transparency on FDA’s evaluation process and evidentiary standards, and improving awareness of drug labeling as an information resource. View full prescribing information for Temodar . On Thursday, the FDA approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda). Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation, and evaluation of evidence for independent FDA review. Project Renewal is intended to keep older, commonly prescribed oncology drugs^ labeling up-to-date, while providing transparency on FDA^s evaluation process and evidentiary standards, and improving awareness of drug labeling as an information resource. View full prescribing information for Temodar . On Thursday, the FDA announced the availability of draft guidance for industry that will help ensure that animal owners who are considering having their pet participate in a clinical study for a new animal drug understand the risks and benefits of their participation. Draft Guidance for Industry (GFI) #282, entitled “ Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals ,” outlines the basic elements of informed consent in animal drug clinical studies. The FDA is accepting public comment on the draft guidance until November 14, 2023. On Thursday, the FDA announced the availability of draft guidance for industry that will help ensure that animal owners who are considering having their pet participate in a clinical study for a new animal drug understand the risks and benefits of their participation. Draft Guidance for Industry (GFI) #282, entitled ^ Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals ,^ outlines the basic elements of informed consent in animal drug clinical studies. The FDA is accepting public comment on the draft guidance until November 14, 2023. On Thursday, the FDA and its regulatory counterparts in Mexico reported continued progress in strengthening food safety at the third annual executive meeting of the Food Safety Partnership September 12-13. The Acting CFSAN Director and Acting Deputy Associate Commissioner for Regulatory Affairs, led the US delegation with the goal of protecting public health through the prevention of foodborne diseases in human foods, by using modern approaches and preventive practices based on technical and scientific evidence, health surveillance, and verification measures. On Wednesday, the FDA granted marketing authorization to the ensoETM, a multi-lumen silicon tube intended to be inserted into a patient’s esophagus to control the patient’s temperature and to reduce the likelihood of ablation-related esophageal injury during radiofrequency cardiac ablation. The ensoETM works by connecting to compatible FDA-cleared external heat exchanger and cooling systems. It is also intended to provide gastric decompression and suctioning. This marketing authorization brings to market an additional option to prevent thermal injury during cardiac ablation procedures. On Monday, the FDA published the FDA Voices: “ Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy ,” by: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER) and Amy Ramanadham, PharmD, MS, Staff Director of Drug Safety Operations, CDER. Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide useful information for product labeling. The Duke-Margolis Center for Health Policy, under a cooperative agreement with the FDA, is holding a two-day public workshop on Sep. 18-19 to discuss pregnancy safety studies. At the workshop, attendees will assess the current processes to collect and evaluate postapproval pregnancy safety information and consider ways to advance this field of research to generate timely pregnancy safety data. On Monday, the FDA published the FDA Voices: ^ Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy ,^ by: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER) and Amy Ramanadham, PharmD, MS, Staff Director of Drug Safety Operations, CDER. Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide useful information for product labeling. The Duke-Margolis Center for Health Policy, under a cooperative agreement with the FDA, is holding a two-day public workshop on Sep. 18-19 to discuss pregnancy safety studies. At the workshop, attendees will assess the current processes to collect and evaluate postapproval pregnancy safety information and consider ways to advance this field of research to generate timely pregnancy safety data. This week, the FDA announced the public workshop “ Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation .” The purpose of this workshop is to stimulate discussion among the FDA, academicians, and industry on endpoint and trial design to promote developing safe and effective medications without long term side effects for kidney transplantation, which is an area of unmet need. The meeting will be held Thursday, November 9 on-site and virtually. Registration is required for both online and on-site attendance. This week, the FDA announced the public workshop ^ Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation .^ The purpose of this workshop is to stimulate discussion among the FDA, academicians, and industry on endpoint and trial design to promote developing safe and effective medications without long term side effects for kidney transplantation, which is an area of unmet need. The meeting will be held Thursday, November 9 on-site and virtually. Registration is required for both online and on-site attendance. This week, the FDA announced the public workshop ^ Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation .^ The purpose of this workshop is to stimulate discussion among the FDA, academicians, and industry on endpoint and trial design to promote developing safe and effective medications without long term side effects for kidney transplantation, which is an area of unmet need. The meeting will be held Thursday, November 9 on-site and virtually. Registration is required for both online and on-site attendance. This week, the FDA supported the open-ended seizure of bulk dry food products, both ready-to-eat (RTE) and non-ready to eat food products stored at Gold Coast Distributors , Inc. (Gold Coast) DBA Shah Distributors in California, based on insanitary conditions that may have resulted in the contamination of food products. The open-ended seizure includes all FDA-regulated food products stored anywhere on the property including various bulk dried lentils, beans, grains, RTE snack foods, as well as frozen food products. The firm also repacks dried beans and lentils under the Shah’s Deer brand. Related Information FDA Newsroom ### The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.    Inquiries    Media:    FDA Office of Media Affairs     888-INFO-FDA                    Consumer:  888-INFO-FDA      Inquiries    Media:    FDA Office of Media Affairs     888-INFO-FDA                    Consumer:  888-INFO-FDA



For Immediate Release:
September 15, 2023




FDA Roundup: September 15, 2023

美国食品药品监督管理局综述：2023 年 9 月 15 日

For Immediate Release: September 15, 2023

Today, the FDA issued the draft guidance ` Labeling for Biosimilar and Interchangeable Biosimilar Products ` and corresponding Notice of Availability (NOA). In this draft guidance, the FDA outlines its recommendations for biosimilar and interchangeable biosimilar product labeling. The FDA has now approved 42 biosimilar products, including four interchangeable biosimilars, and has gained valuable experience about labeling considerations for biosimilar and interchangeable biosimilar products. This guidance considers that experience and includes recommendations on labeling for interchangeable biosimilar products and other topics. For information on how to submit comments, please visit https://www.regulations.gov/docket/FDA-2016-D-0643

On Thursday, the FDA issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech. These products were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped the FDA to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.

On Thursday, the FDA reminded consumers in It`s a Good Time to Get Your Flu Vaccine that FDA-approved flu vaccines prevent influenza and provide important benefits. Getting vaccinated in the fall can lower your chances of getting the flu. Haven`t had your flu shot yet? It`s not too late. Every flu season is different. Your best defense against the flu is to get a vaccine every year.

On Thursday, the FDA issued an update to the final guidance: Breakthrough Devices Program . The updates align with the actions outlined in the FDA`s Center for Devices and Radiological Health Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities. The FDA has also updated the Breakthrough Devices Program website to update the device designations data and the marketing authorizations list with information from April 1 to June 30, 2023 .

On Thursday, the FDA issued an alert to parents and caregivers about LittleOak infant formulas that are currently being voluntarily recalled by the company. The products have been sold in the U.S. illegally because the company has not submitted the required premarket notification. Premarket notifications for new infant formula are intended to demonstrate the safety and nutritional adequacy of the formula by providing the FDA the opportunity to review key information about ingredients in the product, key nutritional information, and manufacturing information, among other things, before the product is available long-term on the U.S. market. It is prohibited to introduce into U.S. commerce a new infant formula without submitting a premarket notification to the FDA. The FDA also expressed concerns that preparation instructions on the label of the LittleOak infant formula containers do not align with measurements commonly displayed on infant formula bottles in the U.S., which may pose challenges to caregivers and impede their ability to properly mix the formula at the appropriate concentration.

On Thursday, the FDA approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda). Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation, and evaluation of evidence for independent FDA review. Project Renewal is intended to keep older, commonly prescribed oncology drugs` labeling up-to-date, while providing transparency on FDA`s evaluation process and evidentiary standards, and improving awareness of drug labeling as an information resource. View full prescribing information for Temodar .

On Thursday, the FDA announced the availability of draft guidance for industry that will help ensure that animal owners who are considering having their pet participate in a clinical study for a new animal drug understand the risks and benefits of their participation. Draft Guidance for Industry (GFI) #282, entitled ` Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals ,` outlines the basic elements of informed consent in animal drug clinical studies. The FDA is accepting public comment on the draft guidance until November 14, 2023.

On Thursday, the FDA and its regulatory counterparts in Mexico reported continued progress in strengthening food safety at the third annual executive meeting of the Food Safety Partnership September 12-13. The Acting CFSAN Director and Acting Deputy Associate Commissioner for Regulatory Affairs, led the US delegation with the goal of protecting public health through the prevention of foodborne diseases in human foods, by using modern approaches and preventive practices based on technical and scientific evidence, health surveillance, and verification measures.

On Wednesday, the FDA granted marketing authorization to the ensoETM, a multi-lumen silicon tube intended to be inserted into a patient`s esophagus to control the patient`s temperature and to reduce the likelihood of ablation-related esophageal injury during radiofrequency cardiac ablation. The ensoETM works by connecting to compatible FDA-cleared external heat exchanger and cooling systems. It is also intended to provide gastric decompression and suctioning. This marketing authorization brings to market an additional option to prevent thermal injury during cardiac ablation procedures.

On Monday, the FDA published the FDA Voices: ` Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy ,` by: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER) and Amy Ramanadham, PharmD, MS, Staff Director of Drug Safety Operations, CDER. Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide useful information for product labeling. The Duke-Margolis Center for Health Policy, under a cooperative agreement with the FDA, is holding a two-day public workshop on Sep. 18-19 to discuss pregnancy safety studies. At the workshop, attendees will assess the current processes to collect and evaluate postapproval pregnancy safety information and consider ways to advance this field of research to generate timely pregnancy safety data.

This week, the FDA announced the public workshop ` Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation .` The purpose of this workshop is to stimulate discussion among the FDA, academicians, and industry on endpoint and trial design to promote developing safe and effective medications without long term side effects for kidney transplantation, which is an area of unmet need. The meeting will be held Thursday, November 9 on-site and virtually. Registration is required for both online and on-site attendance.

This week, the FDA supported the open-ended seizure of bulk dry food products, both ready-to-eat (RTE) and non-ready to eat food products stored at Gold Coast Distributors , Inc. (Gold Coast) DBA Shah Distributors in California, based on insanitary conditions that may have resulted in the contamination of food products. The open-ended seizure includes all FDA-regulated food products stored anywhere on the property including various bulk dried lentils, beans, grains, RTE snack foods, as well as frozen food products. The firm also repacks dried beans and lentils under the Shah`s Deer brand.

今天,美国食品药品监督管理局发布了`生物仿制药和可互换生物仿制药产品标签`指南草案和相应的可用性通知(NOA)。在本指南草案中,美国食品药品监督管理局概述了其对生物仿制药和可互换生物仿制药产品标签的建议。该美国食品药品监督管理局现已批准42种生物类似药产品,包括四种可互换的生物类似药,并在生物类似药和可互换生物类似药产品的标签考虑方面积累了宝贵的经验。本指南考虑了这一经验,并包括关于可互换生物仿制药产品标签和其他主题的建议。有关如何提交意见的信息,请访问 https://www.regulations.gov/docket/ 美国食品药品监督管理局-2016-D-0643

周四,美国食品药品监督管理局向15家在线零售商和三家制造商和/或分销商发出警告信,指控他们销售或分销未经授权的电子烟产品。此外,在一个案例中,零售商非法向未成年购买者出售产品。警告信引用了一系列流行且吸引年轻人的电子烟产品,包括一次性产品,以Elf Bar,EB Design,Lava,Cali,Bang和Kangertech等品牌销售。这些产品是通过快速监测和数据驱动的调查方法确定的。零售销售数据、来自青年调查的新内部数据以及其他数据来源帮助美国食品药品监督管理局确定了这些吸引青年的产品的日益普及,这些产品随后被优先调查整个供应链,从制造商到分销商再到零售商。

周四,美国食品药品监督管理局在`现在是获得流感疫苗的好时机`中提醒消费者,美国食品药品监督管理局批准的流感疫苗可以预防流感并提供重要益处。在秋季接种疫苗可以降低患流感的机会。还没有接种流感疫苗?现在还为时不晚。每个流感季节都是不同的。你对流感最好的防御是每年接种疫苗。

周四,美国食品药品监督管理局发布了对最终指南的更新:突破性设备计划 。这些更新与美国食品药品监督管理局设备和放射卫生战略重点中心概述的行动一致,通过支持解决卫生不公平的新技术和现有技术的创新来促进卫生公平。美国食品药品监督管理局还更新了突破性设备计划网站,以更新设备名称数据和营销授权列表,其中包含 2023 年 4 月 1 日至 6 月 30 日的信息。

周四,美国食品药品监督管理局向父母和护理人员发出了有关LittleOak婴儿配方奶粉的警报,这些配方奶粉目前正在由该公司自愿召回。这些产品在美国非法销售,因为该公司没有提交所需的上市前通知。新婴儿配方奶粉的上市前通知旨在通过为美国食品药品监督管理局提供机会,在产品在美国市场上长期上市之前,通过查看有关产品成分的关键信息、关键营养信息和制造信息等,来证明配方奶粉的安全性和营养充足性。禁止在未向美国食品药品监督管理局提交上市前通知的情况下将新的婴儿配方奶粉引入美国商业。美国食品药品监督管理局还表示担心,LittleOak婴儿配方奶粉容器标签上的制备说明与美国婴儿配方奶粉瓶上通常显示的测量值不一致,这可能会给护理人员带来挑战,并阻碍他们以适当浓度正确混合配方奶粉的能力。

周四,美国食品药品监督管理局批准了替莫唑胺(Temodar,默克)在项目更新下的更新标签,这是一项肿瘤学卓越中心(OCE)计划,旨在更新旧肿瘤药物的标签信息,以确保信息具有临床意义和科学最新性。这是该试点计划下第二种获得标签更新的药物。在项目更新下获得批准的第一种药物是卡培他滨(Xeloda)。项目更新是一项合作计划,利用外部肿瘤学专家和早期职业科学家来审查现有的已发表文献,并在选择、管理和评估证据以获得第一手经验,以进行独立美国食品药品监督管理局审查。项目更新旨在使较旧的,常用处方的肿瘤药物标签保持最新,同时为美国食品药品监督管理局的评估过程和证据标准提供透明度,并提高对药物标签作为信息资源的认识。查看 特莫达尔 的完整处方信息 .

周四,美国食品药品监督管理局宣布了行业指南草案的可用性,这将有助于确保正在考虑让宠物参与新动物药物临床研究的动物主人了解他们参与的风险和益处。行业指南草案(GFI)#282,题为`招募客户拥有的伴侣动物的研究的知情同意书`,概述了动物药物临床研究中知情同意的基本要素。美国食品药品监督管理局正在接受公众对指南草案的意见,截止日期为 2023 年 11 月 14 日。

周四,墨西哥美国食品药品监督管理局及其监管部门在9月12日至13日的食品安全伙伴关系第三次年度执行会议上报告了加强食品安全的持续进展。CFSAN代理主任兼监管事务代理副协理专员率领美国代表团的目标是通过使用基于技术和科学证据的现代方法和预防措施,通过预防人类食品中的食源性疾病来保护公众健康,健康监测和验证措施。

周三,美国食品药品监督管理局授予ensoETM上市许可,ensoETM是一种多腔硅管,旨在插入患者的食道,以控制患者的体温,并减少射频心脏消融期间与消融相关的食道损伤的可能性。ensoETM通过连接到兼容的美国食品药品监督管理局清除的外部热交换器和冷却系统来工作。它还旨在提供胃减压和抽吸。该销售授权为市场带来了一种额外的选择,以防止心脏消融手术中的热损伤。

周一,美国食品药品监督管理局发表了美国食品药品监督管理局之声:`优化批准后安全性研究以扩大怀孕期间药物使用的数据生成`,作者:Patrizia Cavazzoni,医疗器械,药物评估和研究中心(CDER)主任和Amy Ramanadham,PharmD,MS,CDER药物安全运营主任。批准后妊娠安全性研究(或批准后关注药物使用的研究)可以帮助指导临床实践,并为产品标签提供有用的信息。根据与美国食品药品监督管理局的合作协议,杜克-马戈利斯卫生政策中心将于9月18日至19日举行为期两天的公开研讨会,讨论怀孕安全性研究。在研讨会上,与会者将评估收集和评估批准后怀孕安全信息的当前流程,并考虑如何推进这一研究领域,以及时生成妊娠安全数据。

本周,美国食品药品监督管理局宣布了公开研讨会`终点和试验设计,以推进肾移植药物开发`。本次研讨会的目的是激发美国食品药品监督管理局、学者和行业之间关于终点和试验设计的讨论,以促进开发安全有效的药物,对肾脏没有长期副作用移植,这是一个需求未得到满足的领域。会议将于 11 月 9 日星期四现场和虚拟举行。在线和现场出席都需要注册。

本周,美国食品药品监督管理局支持无限期缉获散装干粮产品,包括储存在加利福尼亚州黄金海岸分销商公司(黄金海岸)DBA Shah Distributors的即食(RTE)和非即食食品,基于可能导致食品污染的不卫生条件。开放式缉获包括储存在物业任何地方的所有美国食品药品监督管理局管制食品,包括各种散装干扁豆、豆类、谷物、RTE 休闲食品以及冷冻食品。该公司还以Shah`s Deer品牌重新包装干豆和扁豆。

美敦力(上海)管理有限公司报告,由于临床医生程控仪平板电脑已在开发服务器上注册,而非生产服务器上注册,且预期仅供美敦力人员进行产品演示或培训。生产商美敦力公司Medtronic Inc.对神经调控设备程控仪(国械注进20192120588)主动召回。召回级别为三级召回。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》。    附件:医疗器械召回事件报告表                                                      2023年9月15日美敦力(上海)管理有限公司召回报 表.pdf美敦力公司Medtronic Inc.对神经调控设备程控仪主动召回

美敦力公司Medtronic Inc.对神经调控设备程控仪主动召回

美敦力(上海)管理有限公司报告,由于临床医生程控仪平板电脑已在开发服务器上注册,而非生产服务器上注册,且预期仅供美敦力人员进行产品演示或培训。生产商美敦力公司Medtronic Inc.对神经调控设备程控仪(国械注进20192120588)主动召回。召回级别为三级召回。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》。

美敦力(上海)管理有限公司召回报 表.pdf

"Smith & Nephew, Inc., a subsidiary of Smith & Nephew International Trading (Shanghai) Co., Ltd., is initiating a voluntary recall of the Total Knee System - Zirconium-Niobium Alloy Femoral Component (National Medical Products Administration registration number: 20153132542) due to packaging errors on certain products. The recall has been classified as a Level II recall."

施乐辉医用产品国际贸易(上海)有限公司报告,由于部分产品包装错误,生产商美国施乐辉有限公司Smith & Nephew, Inc. 对全膝关节系统-锆铌合金股骨髁(国械注进20153132542)主动召。召回级别为二级召回。

施乐辉医用产品国际贸易(上海)有限公司报告,由于部分产品包装错误,生产商美国施乐辉有限公司Smith & Nephew, Inc. 对全膝关节系统-锆铌合金股骨髁(国械注进20153132542)主动召。召回级别为二级召回,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》。    附件:医疗器械召回事件报告表                                                      2023年9月15日施乐辉医用产品国际贸易(上海)有限公司召回报表.pdf美国施乐辉有限公司Smith & Nephew, Inc. 对全膝关节系统-锆铌合金股骨髁主动召回

Smith & Nephew, Inc., a subsidiary of Smith & Nephew International Trading (Shanghai) Co., Ltd., is initiating a voluntary recall of the Total Knee System - Zirconium-Niobium Alloy Femoral Component.

美国施乐辉有限公司Smith & Nephew, Inc. 对全膝关节系统-锆铌合金股骨髁主动召回

施乐辉医用产品国际贸易(上海)有限公司报告,由于部分产品包装错误,生产商美国施乐辉有限公司Smith & Nephew, Inc. 对全膝关节系统-锆铌合金股骨髁(国械注进20153132542)主动召。召回级别为二级召回,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》。

施乐辉医用产品国际贸易(上海)有限公司召回报表.pdf

富士胶片(中国)投资有限公司报告,由于部分特定批次存在CEDM选配功能不包含在日本当地注册认证适用范围内,可能会造成使用误导,生产商富士胶片株式会社对数字化乳腺X射线诊断系统(国械注进20143306002、国械注进20143066002)主动召回。召回级别为二级召回。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》。    附件:医疗器械召回事件报告表                                                      2023年9月15日富士胶片(中国)投资有限公司召回报表.pdf富士胶片株式会社对数字化乳腺X射线诊断系统主动召回

富士胶片株式会社对数字化乳腺X射线诊断系统主动召回

富士胶片(中国)投资有限公司报告,由于部分特定批次存在CEDM选配功能不包含在日本当地注册认证适用范围内,可能会造成使用误导,生产商富士胶片株式会社对数字化乳腺X射线诊断系统(国械注进20143306002、国械注进20143066002)主动召回。召回级别为二级召回。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》。

富士胶片(中国)投资有限公司召回报表.pdf