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September 17, 2020, Covington Alert

On September 14, 2020, U.S. Customs and Border Protection (CBP) announced five Withhold Release Orders (WROs) against products from certain factories and companies doing business primarily in the Xinjiang Uyghur Autonomous Region (XUAR) of China based on allegations of forced labor. CBP and other U.S. government departments and agencies have repeatedly stated ...

September 17, 2020, Covington Alert

Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and mitigating ...

September 15, 2020, Covington Alert

The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders ...

September 15, 2020, Covington Alert

The first half of September has seen two major regulatory updates from USDA’s Food Safety and Inspection Service (FSIS). First, on September 14, 2020, FSIS published a proposed rule to expand the circumstances under which FSIS will generically approve the labels of meat, poultry, and egg products, which specifically proposes that FSIS will cease evaluating ...

September 14, 2020, Covington Alert

The EU Regulation on Foreign Direct Investment (2019/452) (the “EU FDI Regulation”) will enter into force fully on October 11, 2020. Most notably, on this date, a cooperation and information sharing mechanism among Member States and the European Commission in respect of foreign direct investment (“FDI”) that has an “EU-dimension” will come into effect.

September 14, 2020, Covington Alert

The English High Court has recently awarded damages in a data privacy case, with two features of particular interest1. First, the nature of the claim is more reminiscent of a claim in defamation than for data privacy breaches, which is a development in the use of data protection legislation. Secondly, the damages awarded (perhaps influenced by the nature of the ...

September 11, 2020, Covington Alert

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

September 9, 2020, Covington Alert

On September 1, 2020, the Office of Management and Budget issued a highly-anticipated interim final rule (“Rule”) implementing the Federal Acquisition Supply Chain Security Act. Consistent with the U.S. Government's increasingly sharp focus on supply chain security, the Rule authorizes the Executive Branch to exclude indefinitely “covered articles” (products and ...

September 8, 2020, Covington Alert

On August 26, 2020, the Securities and Exchange Commission (the ”SEC”) amended the definitions of “accredited investor” in Rule 501(a) of Regulation D and “qualified institutional buyer” (“QIB”) in Rule 144A, each under the Securities Act of 1933 (the “Securities Act”). These amendments are part of the SEC’s broader effort to simplify, harmonize, and improve the ...