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[行业报告] Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations 进入全文

FDA 网站

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. This guidance is intended to provide recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for orally administered drug products in investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and their supplements. This guidance contains advice on how to meet the BA and BE requirements set forth in part 320 (21 CFR part 320) as they apply to dosage forms intended for oral administration. The guidance is also generally applicable to nonorally administered drug products where reliance on systemic exposure measures is suitable to document BA and BE (e.g., transdermal delivery systems and certain rectal and nasal drug products). We believe that the guidance will be useful for applicants planning to conduct BA and BE studies during the IND period for an NDA, BE studies intended for submission in an ANDA, and BE studies conducted in the post approval period for certain changes in both NDAs and ANDAs.

[行业报告] 荃银高科公司深度研究报告:转基因商业化进程提速,公司高成长弹性可期 进入全文

华西证券

 快速成长的现代高科技种业公司。荃银公司是一家“以种业为核心,农业服务为延伸,探索和创新农业多元化发展”的现代高科技种业企业。主要从事优良水稻、玉米、小麦等主要农作物种子的研发、繁育、推广、服务。2015-2019年,公司营业收入从6.07亿元增长至11.54亿元,CAGR+17.39%,归母净利从0.22亿元快速增长至0.95亿元,CAGR+43.77%。2020Q1,公司实现营收1.77亿元,同比增长26.45%,保持快速增长节奏;受疫情影响,公司归母净利增速有所放缓,实现归母净利润882万元,同比仅增长7.92%。从收入结构上看,水稻、玉米种子是公司主要的收入来源。2019年,公司水稻、玉米、小麦种子销售收入占比分别为59.55%、9.87%以及6.65%,订单粮食业务收入占比15.65%。种业拐点即现,公司利润高增长可期:玉米:从供给端来看,2016年玉米临储政策取消,种植玉米收益下降,种植户种植积极性降低,种植面积连年下降,库存已下降至低位,截至2019年,临储玉米库存结余量约5689.39万吨。同时受草地贪夜蛾病虫害影响,我国玉米产量承压。从需求端来看,生猪产能触底回升,猪鸡替代效应下禽链高景气,饲料增量需求带动玉米需求上行。我们认为,需求趋旺背景下供给端承压,叠加库存已处于历史底部,我国玉米行业拐点临近。水稻:从需求端来看,水稻是我国第二大粮食品种,年消费量稳定在2万吨左右;从供给端来看,受高库存压力影响,我国稻谷最低收购价连年下调,库存开始进入加速去化阶段。同时考虑到多国蝗灾泛滥,很可能会造成全球稻谷减产,从而对我国稻谷市场产生冲击。我们认为,种子行业拐点加速到来,公司作为国内高速成长的种子企业,利润有望快速释放。

[行业报告] Short-term impacts of COVID-19 on the Malawian economy: Initial results 进入全文

IFPRI

This Report describes the initial results of modeling undertaken by IFPRI to assess the short-run impacts of the COVID-19 control measures on the Malawian economy. We also consider the short-run effects of external shocks associated with disruptions in trade, investment, and remittance flows on the Malawian economy, as well as two medium-term paths assuming either faster or slower recovery during the remainder of 2020. This analysis has been undertaken in order to inform the policy response to the COVID-19 pandemic in Malawi and represents a first pass attempt to measure the short-term economic impacts of COVID-19 on the Malawian economic. It should be noted that, unlike NPC (2020) our estimates of the economic impact of the COVID-19 on the Malawian economy do not extend beyond 2020 and do not try to set a value on loss of life or life-years. They do, however, allow for detailed breakdown of the direct and indirect impacts of COVID-19 on different sectors and sub-sectors of the Malawian economy.

[行业报告] Impacts of agricultural policies on productivity and sustainability performance in agriculture: A literature review 进入全文

OECD

This report reviews the evidence base on how agricultural policies impact environmental sustainability and productivity of the agriculture sector, including the potentially contradictory signals policies may send. It considers impacts for specific policy types, classified according to the OECD’s Producer Support Estimate (PSE) classification for agricultural support. At the farm level, key pathways for environmental impacts identified in the literature are firstly incentivising a change in agricultural production at the intensive margin, extensive margin or entry-exit margin, and secondly the dynamic impacts of land use choice. Beyond this, policies can also affect agriculture’s environmental performance by stimulating (or stifling) the provision of environmental services. Environmental impacts from agricultural policy depend on several factors. Individual responses to economic incentives created by agricultural policies vary, producing variations in environmental impacts. Variation also occurs due to location-specific physical factors, including landscape characteristics, as well as the cumulative effects of decisions across actors and across time. Finally, impacts may differ across scales.

[行业报告] The Future of US Agricultural and Rural Development Policy 进入全文

AEI

Most of the presidential candidates, including President Donald Trump, support using taxpayer funds to provide direct subsidies to farmers through price support, federal crop insurance, and other farm income safety-net programs. While President Trump has proposed cutting crop insurance subsidies in his annual budgets, he has provided unprecedented levels of ad hoc assistance—as much as $28 billion—to compensate farm owners for losses they might have incurred because of the administration’s trade war with China. Most Democratic candidates would target government farm income safety-net and conservation program outlays more toward small and middle-sized farms and away from large farms. All the Democratic Party candidates considered in this report embrace the broad tenets of the Green New Deal and would support policies to reduce carbon emissions and mitigate climate change, including public investments in agricultural research programs. President Trump ostensibly opposes all climate change initiatives that could possibly affect job growth in the US.

[行业报告] 《中国电子商务报告(2019)》 进入全文

商务部电子商务和信息化司

2019年,农村电商进入规模化专业化发展阶段,跨境电商成为外贸转型升级的重要方向。全国农村网络零售额达1.7万亿元,同比增长19.1%;农产品网络零售额3975亿元,同比增长27%。截至2019年,电子商务进农村综合示范对全国832个国家级贫困县实现全覆盖,电商扶贫对接、“三品一标”认证深入实施,工业品下行、农产品上行的双向渠道进一步畅通,“下沉市场”的消费潜力得到释放。通过海关跨境电子商务管理平台零售进出口商品总额达1862.1亿元,同比增长38.3%。新增24个跨境电商综合试验区,截至2019年年底,试验区总数达到59个,成熟的经验做法加快向全国复制推广,跨境电商政策体系不断完善。

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