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Action Required for Importers Impacted by COVID-19

Client Alert | 1 min read | 03.24.20

USTR Seeks Comments on Removal of Tariffs on Certain Imports from China that Assist the U.S. Coronavirus Response

The Office of the U.S. Trade Representative (USTR) is seeking comments to remove Section 301 tariffs on certain imports from China that could help support the United States COVID-19 response. The USTR recently granted approximately 200 exclusions from the tariffs on China that covered personal protective equipment products, including medical masks, examination gloves, antiseptic wipes, and other medical-care related items, as a response to the COVID-19 outbreak.

The March 20, 2020, notice is seeking comments on whether a medical-care product is “needed to respond to the COVID-19 outbreak.” The Comment window will be open until at least June 25, 2020, and may be extended. 

Each comment specifically must identify the particular product of concern and explain precisely how the product relates to the response to the COVID-19 outbreak. This notice does not replace the current ongoing exclusion process. Comments may be submitted until June 25, 2020 (or until a later date if needed). However, to facilitate timely consideration, interested parties should submit comments as soon as possible.


Insights

Client Alert | 7 min read | 01.10.25

New Draft Guidance From FDA Explains When an Accelerated Approval Trial Is “Underway”

On January 6, with increased attention and scrutiny from patients, providers, developers, and payors on the accelerated approval pathway for drugs, the Food and Drug Administration (FDA) released new draft guidance for industry on what it means for a drug’s confirmatory trial to be “underway” under section 506(c) of the Federal Food, Drug, and Cosmetic Act....