category government-administration 
Arnold Porter
AUGUST 20, 2021
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. ???????????????. ”?????????????????????????????.
Union of Concerned Scientists
DECEMBER 20, 2022
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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Arnold Porter
JUNE 2, 2021
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
Arnold Porter
DECEMBER 20, 2021
This Advisory provides an update on several recently issued US Food and Drug Administration (FDA or the Agency) draft guidance documents and advice addressing areas of increased attention.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.
Arnold Porter
AUGUST 12, 2021
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.
Arnold Porter
JANUARY 21, 2022
In October 2021, we discussed the U.S. Department of Justice's Procurement Collusion Strike Force and four types of business activities in government contracting that pose antitrust risk. 18, 2021), [link]. ]] pled guilty to rigging bids for U.S. In a September 2021 Minnesota concrete contractor case,[[N: Press Release, U.S.
Arnold Porter
JUNE 2, 2021
On March 2, 2021, Virginia Governor Ralph Northam signed into law the Consumer Data Protection Act (the VCDPA or the Act), making Virginia the second state, following California, to grant consumers broad privacy rights with respect to their personal information as collected by businesses both within and outside the state.
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