Accuitis, Inc.

NEW YORK, June 13, 2022 /PRNewswire/ -- The proteasome inhibitors market is concentrated, and the vendors are deploying growth strategies such as strategic alliances to compete in the market. The market size is expected to grow by USD 2.20 bn from 2021 to 2026. However, the growth momentum of the market will decelerate at a CAGR of 7.4% during the forecast period. For more information about market dynamics, View our Sample Report Now Technavio has announced its latest market research report titled Proteasome Inhibitors Market by Product and Geography - Forecast and Analysis 2022-2026 Top Key players in Proteasome Inhibitors Market AbbVie Inc. Accuitis Inc. Amgen Inc. Bristol Myers Squibb Co. Cantex Pharmaceuticals Inc. Fresenius SE and Co. KGaA Johnson and Johnson Takeda Pharmaceutical Co. Ltd. TG Therapeutics Inc. Find more information about key vendors and their offerings. Download an Exclusive Sample Report Market Driver and Challenge The huge unmet need is one of the key drivers of the market. For instance, the market has very few approved therapies for the treatment of pancreatic cancer. Various vendors are developing proteasome inhibitors in the late stages of clinical trials for multiple myeloma and two drugs for pancreatic cancer. Thus, the unmet need is expected to attract various large and mid-sized pharmaceutical vendors to conduct studies and launch products. The threat from biologics is challenging the growth of the market. Various vendors are developing drugs for the treatment of solid tumors such as pancreatic cancer and malignant melanoma. For instance, AbbVie is developing KYPROLIS, which is in the phase II stage of clinical trials for the treatment of prostate cancer and renal cell carcinoma. Similarly, Takeda is developing VELCADE, which is in the Phase II stage of clinical trials for the treatment of glioma. Vendors face a threat from substitutes, with the increasing number of highly effective biologics such as PD-1 and PD-L1 inhibitors. Market Segmentation Proteasome Inhibitors Market Split by Product VELCADE: This segment will have the highest market share growth during the forecast period. VELCADE inhibits the proteasome enzyme complex within the cell, which is a part of the cellular machinery. It also plays a major role in the regulation of cell division and cell survival. Such factors of VELCADE will drive the growth of the proteasome inhibitors market during the forecast period. KYPROLIS NINLARO Others Proteasome Inhibitors Market Split by Geography North America: This region will have the highest market share growth during the forecast period. This growth is attributed to factors such as advanced healthcare infrastructure. However, market growth in this region will be slower than the growth of the market in other regions. The US and Canada are the key countries for the proteasome inhibitors market in North America. Europe Asia Rest of World (ROW) Imperative Insights on the following aspects: What was the size of the global proteasome inhibitors industry by value in 2020? What will be the size of the global proteasome inhibitors industry in 2026? What factors are affecting the strength of competition in the global proteasome inhibitors industry? How has the industry performed over the last five years? What are the main segments that make up the global proteasome inhibitors market? Subscribe to our "Basic Plan" billed annually at USD 5000. Get lifetime access to our Technavio Insights Why buy? Identify factors affecting growth prospects across markets. Track competitor gains and losses in market share. Get a Holistic View of the Market Related Reports: BRAF Kinase Inhibitors Market by Product and Geography - Forecast and Analysis 2022-2026 Anaplastic Thyroid Cancer Drugs Market by Product and Geography - Forecast and Analysis 2022-2026 Table of Content: 1 Executive Summary 1.1 Market overview Exhibit 01: Executive Summary – Chart on Market Overview Exhibit 02: Executive Summary – Data Table on Market Overview Exhibit 03: Executive Summary – Chart on Global Market Characteristics Exhibit 04: Executive Summary – Chart on Market by Geography Exhibit 05: Executive Summary – Chart on Market Segmentation by Product Exhibit 06: Executive Summary – Chart on Incremental Growth Exhibit 07: Executive Summary – Data Table on Incremental Growth Exhibit 08: Executive Summary – Chart on Vendor Market Positioning 2 Market Landscape 2.1 Market ecosystem Exhibit 09: Parent market Exhibit 10: Market Characteristics 3 Market Sizing 3.1 Market definition Exhibit 11: Offerings of vendors included in the market definition 3.2 Market segment analysis Exhibit 12: Market segments 3.3 Market size 2021 3.4 Market outlook: Forecast for 2021-2026 Exhibit 13: Chart on Global - Market size and forecast 2021-2026 ($ million) Exhibit 14: Data Table on Global - Market size and forecast 2021-2026 ($ million) Exhibit 15: Chart on Global Market: Year-over-year growth 2021-2026 (%) Exhibit 16: Data Table on Global Market: Year-over-year growth 2021-2026 (%) 4 Five Forces Analysis 4.1 Five forces summary Exhibit 17: Five forces analysis - Comparison between 2021 and 2026 4.2 Bargaining power of buyers Exhibit 18: Chart on Bargaining power of buyers – Impact of key factors 2021 and 2026 4.3 Bargaining power of suppliers Exhibit 19: Bargaining power of suppliers – Impact of key factors in 2021 and 2026 4.4 Threat of new entrants Exhibit 20: Threat of new entrants – Impact of key factors in 2021 and 2026 4.5 Threat of substitutes Exhibit 21: Threat of substitutes – Impact of key factors in 2021 and 2026 4.6 Threat of rivalry Exhibit 22: Threat of rivalry – Impact of key factors in 2021 and 2026 4.7 Market condition Exhibit 23: Chart on Market condition - Five forces 2021 and 2026 5 Market Segmentation by Product 5.1 Market segments Exhibit 24: Chart on Product - Market share 2021-2026 (%) Exhibit 25: Data Table on Product - Market share 2021-2026 (%) 5.2 Comparison by Product Exhibit 26: Chart on Comparison by Product Exhibit 27: Data Table on Comparison by Product 5.3 VELCADE - Market size and forecast 2021-2026 Exhibit 28: Chart on VELCADE - Market size and forecast 2021-2026 ($ million) Exhibit 29: Data Table on VELCADE - Market size and forecast 2021-2026 ($ million) Exhibit 30: Chart on VELCADE - Year-over-year growth 2021-2026 (%) Exhibit 31: Data Table on VELCADE - Year-over-year growth 2021-2026 (%) 5.4 KYPROLIS - Market size and forecast 2021-2026 Exhibit 32: Chart on KYPROLIS - Market size and forecast 2021-2026 ($ million) Exhibit 33: Data Table on KYPROLIS - Market size and forecast 2021-2026 ($ million) Exhibit 34: Chart on KYPROLIS - Year-over-year growth 2021-2026 (%) Exhibit 35: Data Table on KYPROLIS - Year-over-year growth 2021-2026 (%) 5.5 NINLARO - Market size and forecast 2021-2026 Exhibit 36: Chart on NINLARO - Market size and forecast 2021-2026 ($ million) Exhibit 37: Data Table on NINLARO - Market size and forecast 2021-2026 ($ million) Exhibit 38: Chart on NINLARO - Year-over-year growth 2021-2026 (%) Exhibit 39: Data Table on NINLARO - Year-over-year growth 2021-2026 (%) 5.6 Others - Market size and forecast 2021-2026 Exhibit 40: Chart on Others - Market size and forecast 2021-2026 ($ million) Exhibit 41: Data Table on Others - Market size and forecast 2021-2026 ($ million) Exhibit 42: Chart on Others - Year-over-year growth 2021-2026 (%) Exhibit 43: Data Table on Others - Year-over-year growth 2021-2026 (%) 5.7 Market opportunity by Product Exhibit 44: Market opportunity by Product ($ million) 6 Customer Landscape 6.1 Customer landscape overview Exhibit 45: Analysis of price sensitivity, lifecycle, customer purchase basket, adoption rates, and purchase criteria 7 Geographic Landscape 7.1 Geographic segmentation Exhibit 46: Chart on Market share by geography 2021-2026 (%) Exhibit 47: Data Table on Market share by geography 2021-2026 (%) 7.2 Geographic comparison Exhibit 48: Chart on Geographic comparison Exhibit 49: Data Table on Geographic comparison 7.3 North America - Market size and forecast 2021-2026 Exhibit 50: Chart on North America - Market size and forecast 2021-2026 ($ million) Exhibit 51: Data Table on North America - Market size and forecast 2021-2026 ($ million) Exhibit 52: Chart on North America - Year-over-year growth 2021-2026 (%) Exhibit 53: Data Table on North America - Year-over-year growth 2021-2026 (%) 7.4 Europe - Market size and forecast 2021-2026 Exhibit 54: Chart on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 55: Data Table on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 56: Chart on Europe - Year-over-year growth 2021-2026 (%) Exhibit 57: Data Table on Europe - Year-over-year growth 2021-2026 (%) 7.5 Asia - Market size and forecast 2021-2026 Exhibit 58: Chart on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 59: Data Table on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 60: Chart on Asia - Year-over-year growth 2021-2026 (%) Exhibit 61: Data Table on Asia - Year-over-year growth 2021-2026 (%) 7.6 Rest of World (ROW) - Market size and forecast 2021-2026 Exhibit 62: Chart on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 63: Data Table on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 64: Chart on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) Exhibit 65: Data Table on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) 7.7 US - Market size and forecast 2021-2026 Exhibit 66: Chart on US - Market size and forecast 2021-2026 ($ million) Exhibit 67: Data Table on US - Market size and forecast 2021-2026 ($ million) Exhibit 68: Chart on US - Year-over-year growth 2021-2026 (%) Exhibit 69: Data Table on US - Year-over-year growth 2021-2026 (%) 7.8 UK - Market size and forecast 2021-2026 Exhibit 70: Chart on UK - Market size and forecast 2021-2026 ($ million) Exhibit 71: Data Table on UK - Market size and forecast 2021-2026 ($ million) Exhibit 72: Chart on UK - Year-over-year growth 2021-2026 (%) Exhibit 73: Data Table on UK - Year-over-year growth 2021-2026 (%) 7.9 Germany - Market size and forecast 2021-2026 Exhibit 74: Chart on Germany - Market size and forecast 2021-2026 ($ million) Exhibit 75: Data Table on Germany - Market size and forecast 2021-2026 ($ million) Exhibit 76: Chart on Germany - Year-over-year growth 2021-2026 (%) Exhibit 77: Data Table on Germany - Year-over-year growth 2021-2026 (%) 7.10 Canada - Market size and forecast 2021-2026 Exhibit 78: Chart on Canada - Market size and forecast 2021-2026 ($ million) Exhibit 79: Data Table on Canada - Market size and forecast 2021-2026 ($ million) Exhibit 80: Chart on Canada - Year-over-year growth 2021-2026 (%) Exhibit 81: Data Table on Canada - Year-over-year growth 2021-2026 (%) 7.11 France - Market size and forecast 2021-2026 Exhibit 82: Chart on France - Market size and forecast 2021-2026 ($ million) Exhibit 83: Data Table on France - Market size and forecast 2021-2026 ($ million) Exhibit 84: Chart on France - Year-over-year growth 2021-2026 (%) Exhibit 85: Data Table on France - Year-over-year growth 2021-2026 (%) 7.12 Market opportunity by geography Exhibit 86: Market opportunity by geography ($ million) 8 Drivers, Challenges, and Trends 8.1 Market drivers 8.2 Market challenges 8.3 Impact of drivers and challenges Exhibit 87: Impact of drivers and challenges in 2021 and 2026 8.4 Market trends 9 Vendor Landscape 9.1 Overview 9.2 Vendor landscape Exhibit 88: Overview on Criticality of inputs and Factors of differentiation 9.3 Landscape disruption Exhibit 89: Overview on factors of disruption 9.4 Industry risks Exhibit 90: Impact of key risks on business 10 Vendor Analysis 10.1 Vendors covered Exhibit 91: Vendors covered 10.2 Market positioning of vendors Exhibit 92: Matrix on vendor position and classification 10.3 AbbVie Inc. Exhibit 93: AbbVie Inc. - Overview Exhibit 94: AbbVie Inc. - Product / Service Exhibit 95: AbbVie Inc. - Key offerings 10.4 Accuitis Inc. Exhibit 96: Accuitis Inc. - Overview Exhibit 97: Accuitis Inc. - Product / Service Exhibit 98: Accuitis Inc. - Key offerings 10.5 Amgen Inc. Exhibit 99: Amgen Inc. - Overview Exhibit 100: Amgen Inc. - Product / Service Exhibit 101: Amgen Inc. - Key offerings 10.6 Bristol Myers Squibb Co. Exhibit 102: Bristol Myers Squibb Co. - Overview Exhibit 103: Bristol Myers Squibb Co. - Product / Service Exhibit 104: Bristol Myers Squibb Co. - Key offerings 10.7 Cantex Pharmaceuticals Inc. Exhibit 105: Cantex Pharmaceuticals Inc. - Overview Exhibit 106: Cantex Pharmaceuticals Inc. - Product / Service Exhibit 107: Cantex Pharmaceuticals Inc. - Key news Exhibit 108: Cantex Pharmaceuticals Inc. - Key offerings 10.8 Fresenius SE and Co. KGaA Exhibit 109: Fresenius SE and Co. KGaA - Overview Exhibit 110: Fresenius SE and Co. KGaA - Business segments Exhibit 111: Fresenius SE and Co. KGaA - Key news Exhibit 112: Fresenius SE and Co. KGaA - Key offerings Exhibit 113: Fresenius SE and Co. KGaA - Segment focus 10.9 Johnson and Johnson Exhibit 114: Johnson and Johnson - Overview Exhibit 115: Johnson and Johnson - Business segments Exhibit 116: Johnson and Johnson - Key news Exhibit 117: Johnson and Johnson - Key offerings Exhibit 118: Johnson and Johnson - Segment focus 10.10 Takeda Pharmaceutical Co. Ltd. Exhibit 119: Takeda Pharmaceutical Co. Ltd. - Overview Exhibit 120: Takeda Pharmaceutical Co. Ltd. - Product / Service Exhibit 121: Takeda Pharmaceutical Co. Ltd. - Key news Exhibit 122: Takeda Pharmaceutical Co. Ltd. - Key offerings 10.11 TG Therapeutics Inc. Exhibit 123: TG Therapeutics Inc. - Overview Exhibit 124: TG Therapeutics Inc. - Product / Service Exhibit 125: TG Therapeutics Inc. - Key offerings 11 Appendix 11.1 Scope of the report 11.2 Inclusions and exclusions checklist Exhibit 126: Inclusions checklist Exhibit 127: Exclusions checklist 11.3 Currency conversion rates for US$ Exhibit 128: Currency conversion rates for US$ 11.4 Research methodology Exhibit 129: Research methodology Exhibit 130: Validation techniques employed for market sizing Exhibit 131: Information sources 11.5 List of abbreviations Exhibit 132: List of abbreviations About Us Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. 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FDA对临床试验的监管日渐趋严。   在全球，推动临床试验透明性一直都是一个长期存在的问题，记录良好且透明的数据，有助于人们了解药物是如何起效的，也有助于试验结果的复制。同样的，令人失望的临床试验结果也不该再被遮遮掩掩、羞于示人。   2016年开始，美国收紧对临床试验透明度的规定，要求临床试验不论成功与否，都要求研究者完全披露设计与结果。而今年以来，FDA更开始付诸行动，针对违规行为接连向两家公司开出罚单。   近日，因为未能如期按照联邦法律的要求提交研究结果，FDA又第一次警告要对一项临床试验的PI处以罚款。这也是FDA首次扩大了违规目标人员名单，从公司扩展到个人。   01 PI遭警告   8 月 31 日，FDA向洛杉矶外科医生 Andrey Petrikovets 发出警告信，信中指出，该医生在凯斯西储大学（Case Western Reserve）附属的克利夫兰医学中心大学医院进行的一项研究，结果公布的时间超过了限期。   这是一项针对阴道盆底重建手术后不同疼痛方案的研究，已于2018年6月完成，根据联邦法律的规定，研究完成一年后，应将其结果发布在数据库中。   去年7月时，FDA曾致信Petrikovets，告知其没有发布结果。对方在今年1月份回复，正忙于新冠疫情。而在本次警告信发出一天后，再查询ClinicalTrials.gov网站，显示结果已提交。   根据联邦法律的要求， 相关责任方需要为某些适用的临床试验向ClinicalTrials.gov数据库提交注册和总结结果信息。 向FDA提交某些申请或材料的人，也要证明这些申请或材料中引用的适用临床试验符合要求。FDA有权对不符合某些要求的责任方发出通知。   这些违规情况包括未提交所要求的临床试验资料、提交虚假或误导性的临床试验信息。   FDA也有权评估这些违规行为的民事罚款，如果责任方在收到关于未提交所需信息的通知后30天内没有适当的纠正措施，该责任方可能会受到额外的民事罚款。   去年7月，FDA发布有关对违反《FDA 修订法案》（FDAAA）第801节条款的定稿指南： 对单个程序中裁定的所有违法行为，最高罚款不超过1万美元。如果申办者在收到此类违法行为通知后的30天内仍未纠正违法行为，则在违规行为发生后的每一天加收不超过1万美元的罚款，直至纠正违规行为为止。 02 早已对企业“动刀” 定稿指南发布后，依旧有部分申报者未遵守指南要求。根据Trials Tracker数据，近 9900 项临床试验中约有28% 的结果尚未报告给 ClinicalTrials.gov，FDA也未收到任何罚款。   在当大多数人认为这又是一次“雷声大，雨点小”的规定时，终于在今年4月FDA开始行动了。   4月28日，FDA向未能向联邦注册机构提交临床试验必要信息的申办人 Acceleron Pharma 发布不合规通知，并警示可能面临罚款。这是FDA发布定稿指南以来首次发出不合规通知，也被认为是首次采取罚款措施来回应大众对提高临床研究透明度的要求。 FDA表示，早在去年7月就已经因未提交关于Dalantercept药物治疗晚期肾细胞癌的II期试验结果而向Acceleron发出警告信，但Acceleron一直未做出纠正。FDA 指出，Acceleron必须在5月27日之前公布数据，否则将面临每天最高 1 万美元的民事罚款或其它监管行动，包括禁制令或刑事诉讼。   收到通知后，Acceleron 公司表示在试验结果未达到预期后，公司已经于2017年停止了该药物的研发。不过还是会遵守FDA的要求，在规定的30天补救期内，将临床试验结果发布在ClinicalTrials.gov上。 紧接着，今年7月，FDA发出了第二张不合规通知。FDA称，制药公司Accuitis在使用ACU-D1治疗玫瑰痤疮的临床试验中未能按照联邦法规的要求在联邦注册机构提交临床试验结果，已经在去年10月份就该问题致信Accuitis，并要求 “立即提交所有要求的结果信息”。但很显然Accuitis没有遵守FDA的要求。   FDA在不合规通知中指出，Accuitis 必须在30 天之内公布数据，否则将面临每天最高1万美元的民事罚款或其它监管行动。   FDA中心的监管顾问Jan Hewett说：“FDA虽然希望申报者自愿遵守规定，但更多的是希望受监管者了解合规的重要性和不合规时对药物研究和评价带来的潜在不良影响。”

近日，美国两名临床研究人员因伪造临床试验数据被法院分别判处46个月和30个月的监禁，并处以213.45万美元（约1383万元）的罚款。 FDA刑事调查部门表示，发现任何人伪造试验数据都将进行起诉。   本次案件中，52岁的Eduardo Navarro和50岁的Nayade Varona均是Tellus临床研究（Tellus Clinical Research）机构的工作人员。Navarro是一名护士，也是Tellus的副研究员；Varona是Tellus的助理研究协调员。   根据法庭文件，她们承认与他人共同伪造了两项临床试验的数据，通过伪造医疗记录，让文件看起来像是受试者参加了临床试验，但实际上受试者并没有参加。   01  “惯犯” Tellus Tellus是一家临床研究机构，曾与辉瑞、吉利德、武田、勃林格殷格翰和礼来等知名制药公司合作过。 近几年，Tellus所做的临床试验中有一些试验也受到了质疑，包括Braeburn 制药的阿片类药物依赖有关的试验和吉利德的糖尿病药物研究试验。   同时，这次的临床试验数据造假问题并不是Tellus第一次被指控。今年3月， Tellus的老板Fidalgis Font、主要调查员Martin Valdes医生和两位高管Julio Lopez、Duniel Tejeda被指控串谋进行邮件和电汇欺诈，Valdes 和Font 被指控洗钱，Valdes 还进一步被指控向FDA检查员作虚假陈述。   起诉书显示，至少从 2014年2月到2016年7月，4位被告在Tellus 临床研究机构工作期间捏造临床试验数据以牟利。被告在明知受试者不符合参加临床试验标准的情况下仍然招募受试者，并伪造受试者实验室检查结果、医疗记录，虚假陈述受试者正在服用该临床试验研究的药物，但实际上受试者并未服用。目前，此案还在审理中。   FDA刑事调查助理专员Catherine A. Hermsen 说：“临床试验可靠和准确的数据是FDA评估新药的基础。受损的临床试验数据可能会影响FDA对所审查药物安全性和有效性的决定。我们将继续监控、调查那些行为可能破坏FDA批准程序并危害公众健康的人，并将其绳之以法。”   美国司法部民事司代理助理检察长Brian M. Boynton说：“必须保障临床试验数据的准确性和真实性，这对于确保FDA所批药物的安全性至关重要。被告却伪造试验数据，让患者处于危险之中。司法部将追查和起诉那些将个人利益置于公共健康之上的人。”   “伪造临床数据是辜负公众信任，危及消费者安全的行为。”美国检察官Ariana Fajardo Orshan说：“借虚假临床数据危害公众健康并牟利的人，将受到起诉并严惩。起诉这些案件也将继续是我们办公室的首要任务。”   在Navarro和Varona临床试验数据造假的案件中，FDA刑事调查办公室负责调查这起案件；民事法庭消费者保护分部的审判律师劳伦·埃尔夫纳和约书亚·罗斯曼负责对此案进行起诉；美国佛罗里达州南区检察官办公室提供关键援助。   02 愈发严格的FDA   近几年，FDA对于临床试验数据的管理愈发严格。   过去十年，英国和欧洲常常出现制药公司推迟或隐瞒试验数据的情况，引发公众对批准药品安全性的担忧。2019 年 11 月，一项发表在《新英格兰医学杂志》上研究显示，制药公司和学术研究中心在报告人体研究结果方面略有进展，更多的试验结果被公开，但试验数据质量成为大问题。   在数据被推迟公开或被隐藏，甚至提交虚假数据“成风”时，去年7月，FDA发布有关对违反《FDA 修订法案》（FDAAA）第801节条款的定稿指南： 对未注册研究，不向 ClinicalTrial.gov报告结果或提交虚假信息的试验申办者进行处罚，单个程序中裁定的所有违法行为，最高罚款不超过1万美元。如果申办者在收到此类违法行为通知后的30天内仍未纠正违法行为，则在违规行为发生后的每一天加收不超过1万美元的罚款，直至纠正违规行为为止。   定稿指南发布后，依旧有部分申报者未遵守指南要求。根据Trials Tracker数据，近 9900 项临床试验中约有28% 的结果尚未报告给 ClinicalTrials.gov，FDA也未收到任何罚款。   在当大多数人认为这又是一次“雷声大，雨点小”的规定时，终于在今年4月FDA开始行动了。   4月28日，FDA向未能向联邦注册机构提交临床试验必要信息的申办人 Acceleron Pharma 发布不合规通知，并警示可能面临罚款。这是FDA发布定稿指南以来首次发出不合规通知，也被认为是首次采取罚款措施来回应大众对提高临床研究透明度的要求。 FDA表示，早在去年7月就已经因未提交关于Dalantercept药物治疗晚期肾细胞癌的II期试验结果而向Acceleron发出警告信，但Acceleron一直未做出纠正。FDA 指出，Acceleron必须在5月27日之前公布数据，否则将面临每天最高 1 万美元的民事罚款或其它监管行动，包括禁制令或刑事诉讼。   收到通知后，Acceleron 公司表示在试验结果未达到预期后，公司已经于2017年停止了该药物的研发。不过还是会遵守FDA的要求，在规定的30天补救期内，将临床试验结果发布在ClinicalTrials.gov上。   紧接着，今年7月，FDA发出了第二张不合规通知。FDA称，制药公司Accuitis在使用ACU-D1治疗玫瑰痤疮的临床试验中未能按照联邦法规的要求在联邦注册机构提交临床试验结果，已经在去年10月份就该问题致信Accuitis，并要求 “立即提交所有要求的结果信息”。但很显然Accuitis没有遵守FDA的要求。   FDA在不合规通知中指出，Accuitis 必须在30 天之内公布数据，否则将面临每天最高1万美元的民事罚款或其它监管行动。   FDA中心的监管顾问Jan Hewett说：“FDA虽然希望申报者自愿遵守规定，但更多的是希望受监管者了解合规的重要性和不合规时对药物研究和评价带来的潜在不良影响。”   对于临床试验数据的监管，我国药监局也曾采取过雷霆手段。   2015年7月22日，国家食品药品监督管理总局发布《关于开展药物临床试验数据自查核查工作的公告（2015年第117号）》，按“最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问责，确保广大人民群众饮食用药安全”要求，对1622个已申报生产或进口的待审药品注册申请开展药物临床试验数据核查，如有问题主动撤回。对于在规定时间没有提交报告或撤回的申请，总局将进行飞行检查。一旦查出问题，企业将面临“3年内不受理其申请”、“吊销药物临床试验机构的资格”、“列入黑名单”等严格处罚。   彼时，800多家药企面临着“撤，还是不撤”的考验。在感受到此次公告内容并不是说说而已之后，一大批企业纷纷撤回注册申请。这一事件也被医药界称为“722惨案”。   当时中国的临床试验数据质量如何？看到未撤回申请的企业几乎是外企时，便有了答案。“722惨案”的严格监管也为之后的临床试验数据质量奠定了重要基础。   药品作为治病救人的产品，其安全性无疑是最重要的。而药品的安全性需要监管者的严格执法，但最根本上靠的还是药企的自我严格要求和诚实守信。