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Danger Season and Hurricane Season Have Ended, Work for Impacted Communities Has Not

Union of Concerned Scientists

Just like in 2021, a lot of us may be thinking “it was not too bad.” However, 2021 saw the third most active hurricane season since record keeping began in 1851. Note that Fiona made landfall as a Category 1 hurricane and still did a lot of damage—it all boils down to levels of community preparedness on land.

2022 286
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New Developments in China’s Drug Change Management Regulations

Arnold Porter

The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) recently released the Acceptance Review Guideline on Biological Products Changes (for Trial Implementation). Latest Developments in China’s Drug Change Management Regulations. ???????????????. ”?????????????????????????????.

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Why We Can Send A Rover To Mars, But We Can’t Send An Electron From New York to California

Union of Concerned Scientists

Right now, states and the federal government have a choice that will define our country’s options for clean energy and planning the power grid for the challenges ahead. The federal government funds space exploration. The federal government funds space exploration. Shared Duties, with Leadership. New Roles for States.

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Why Energy Bills Will Be Even Higher This Winter

Union of Concerned Scientists

US ratepayers very likely will pay even more for electricity and heating this winter compared to the already-expensive winter of 2021-2022. The US Energy Information Administration is forecasting the wholesale price of gas to reach its highest level since the winter of 2009-2010 in inflation-adjusted terms.

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Research Roundup: FDA Uses Fall and Winter 2021 to Release Significant New Guidance Governing Hot-Button Life Sciences Research Topics

Arnold Porter

This Advisory provides an update on several recently issued US Food and Drug Administration (FDA or the Agency) draft guidance documents and advice addressing areas of increased attention. Several new guidance documents released in the latter half of 2021 take steps to address this need, two of which are highlighted below.

2021 52
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Department of Commerce Eliminates Most Mass Market Encryption Reporting Obligations

Arnold Porter

In addition, the final rule also implements certain modifications to the CCL and associated changes to the EAR as part of the government's continued participation in the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies (Wassenaar Arrangement). c or 5D992.c

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FDA Seeks Comments on Transition of Certain Drugs to Device Status Following Genus DC Circuit Decision

Arnold Porter

This question, and FDA’s discretion to determine a product’s regulatory classification, was at the heart of the DC Circuit’s April 2021 decision in Genus Med. Food and Drug Administration, 994 F.3d Under the FDCA, whether a product is regulated as a drug or device turns on the intended use of the product.