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FDA 对溶酶体贮积症孤儿药的认定——横断面分析
1983 年至 2019 年间，FDA 授予了 124 项孤儿药资格，用于治疗 28 种溶酶体贮积症。孤儿药资格主要针对戈谢病（N = 16）、庞贝病（N = 16）、法布里病（N = 10）、MPS II（N = 10）、MPS I（N = 9）和 MPS IIIA（N = 9），包括酶替代疗法、基因疗法、小分子等。23 种孤儿药获批用于治疗 11 种 LSD。戈谢病（N = 6）、胱氨酸病（N = 5）、庞贝病（N = 3）和法布里病（N = 2）获得多项批准，CLN2、LAL-D、MPS I、II、IVA、VI 和 VII 各获得一项批准。这意味着自 2013 年以来，批准的药物增加了 9 种，可治疗的 LSD 增加了 4 种（CLN2、MPS VII、LAL-D 和 MPS IVA）。孤儿药指定和 FDA 批准之间的平均时间为 89.7 SD 55.00（范围 8-203，N = 23）个月。
FDA 对溶酶体贮积症孤儿药的认定——横断面分析
此预印本的版权所有者于 2020 年 1 月 10 日发布此版本。；https://doi.org/10.1101/2020.01.05.20016568 doi: medRxiv preprint
FDA 针对溶酶体贮积症的孤儿药认定——横断面分析
此预印本的版权所有者于 2020 年 1 月 14 日发布此版本。；https://doi.org/10.1101/2020.01.05.20016568 doi: medRxiv preprint
Parexel Insights报告：FDA最令人垂涎的名称中的新兴趋势可能会告诉我们
上个月我从纽约投资者那里听到的一句话是，[临床]数据对生物技术的数据已经不够了。如今，您必须拥有出色的数据，即首次公开募股，次要产品，甚至可以防止股价下跌。
14830 Carmenita Road Warehouse Project的最终MND
1。INTRODUCTION .............................................................................................................................. 7 1.1.PURPOSE OF THE INITIAL STUDY ............................................................................................................... 7 1.2.DOCUMENT ORGANIZATION .................................................................................................................... 8 2.PROJECT SETTING........................................................................................................................... 9 2.1.项目位置............................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... 9 2.2。EXISTING PROJECT SITE ............................................................................................................................... 9 2.3.EXISTING GENERAL PLAN AND ZONING DESIGNATIONS ................................................................. 9 2.4.SURROUNDING LAND USE, GENERAL PLAN, AND ZONING DESIGNATIONS ............................... 9 3.PROJECT DESCRIPTION ................................................................................................................ 27 3.1.PROJECT OVERVIEW ................................................................................................................................. 27 3.2.PROJECT FEATURES .................................................................................................................................... 27 3.3.GENERAL PLAN AND ZONING ................................................................................................................ 28 3.4.CONSTRUCTION PHASING ...................................................................................................................... 28 3.5.OPERATIONAL CHARACTERISTICS .......................................................................................................... 28 3.6.DISCRETIONARY APPROVALS, PERMITS, AND STUDIES ..................................................................... 29 4.ENVIRONMENTAL CHECKLIST ...................................................................................................... 37 4.1.环境因素可能受到影响.................................................................................................................................................................................................... 37 4.2。DETERMINATION ......................................................................................................................................... 38 5.ENVIRONMENTAL ANALYSIS ....................................................................................................... 41 5.1.AESTHETICS .................................................................................................................................................. 41 5.2.AGRICULTURE AND FORESTRY RESOURCES ........................................................................................ 45 5.3.AIR QUALITY ................................................................................................................................................ 47 5.4.BIOLOGICAL RESOURCES ........................................................................................................................ 57 5.5.CULTURAL RESOURCES ............................................................................................................................. 60 5.6.ENERGY ........................................................................................................................................................ 63 5.7.GEOLOGY AND SOILS ............................................................................................................................. 67 5.8.温室气体排放..................................................................................................................................................................................................................................................................................................................................... 73 5.9。HAZARDS AND HAZARDOUS MATERIALS ............................................................................................. 80 5.10.HYDROLOGY AND WATER QUALITY .................................................................................................... 85 5.11.土地使用和规划........................................................................................................................................................................................................................................................................................................................................................................................................................................... 91 5.12。MINERAL RESOURCES ................................................................................................................................ 99 5.13.NOISE .......................................................................................................................................................... 100 5.14.POPULATION AND HOUSING ............................................................................................................... 109 5.15.PUBLIC SERVICES ...................................................................................................................................... 111 5.16.RECREATION .............................................................................................................................................. 114 5.17.TRANSPORTATION ................................................................................................................................... 115 5.18.TRIBAL CULTURAL RESOURCES .............................................................................................................. 119 5.19.UTILITIES AND SERVICE SYSTEMS.......................................................................................................... 121 5.20.WILDFIRE .................................................................................................................................................... 127 5.21.MANDATORY FINDINGS OF SIGNIFICANCE ..................................................................................... 129 6.DOCUMENT PREPARERS AND CONTRIBUTORS ......................................................................... 132
拟议的平面图859平方英尺的样品
*拟议的平面图应显示以下内容； *Proposed use of the space with room designations and floor levels *A written scope of work *Window/Door size and type (slider, casement, etc) *New Lights, outlets and Smoke/Co detectors *New mechanical appliances with clearances *New walls with a wall section showing stud sizing, insulation and finishes *Stair construction with handrail and guardrail heights and details (if applicable) *Total square footage of the level
二级计划计划报告
4.2.1 Land Use Structure ....................................... 34 4.2.2 General Policies ........................................... 34 4.2.3 Relationship with the Municipality of Central Elgin Land Use Designations and Policies............................................... 36 4.2.4 Harbour Low Density Residential Designation ............................................... 36 4.2.5 Mixed Use 1 Designation ............................ 38 4.2.6 Mixed Use 2 Designation ............................ 38 4.2.7 Commercial Designation ........................... 39 4.2.8 Hotel/Conference Centre Designation .. 40 4.2.9 Harbour Community Facilities Designation ............................................... 41 4.2.10 Harbour Natural Heritage Designation .... 42 4.2.11 Dynamic Beach Designation .................... 42 4.2.12 Natural Hazards Overlay Designation ..... 43