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