Life Sciences and Medical Technologies – Page 2

March 31, 2020September 1, 2020 by Duane Morris

USTR Offers New Section 301 Exclusions for COVID-19 Medical Products

Since our previous two Alerts, on March 13 and 20, describing actions taken in recent weeks by the U.S. Trade Representative (USTR) to exclude numerous medical products imported from China from Section 301 tariffs, the USTR has announced it will accept new Section 301 exclusion requests relating to other products that can be used in the battle against the coronavirus (COVID-19). Such exclusion requests can be submitted for any product that can be used to address the COVID-19 pandemic that has not yet been granted by the USTR, including products with previously denied or currently pending exclusion requests, as well as for products for which requests have not been filed.

To read the full text of this Duane Morris Alert, please visit the firm website.

March 18, 2020August 31, 2020 by Duane Morris

FDA Guidance Aims to Accelerate Availability of COVID-19 Tests

On March 16, 2020, the U.S. Food & Drug Administration (FDA) issued new guidance aimed at accelerating the availability of COVID-19 diagnostic tests developed by laboratories and commercial manufacturers. The guidance, which took immediate effect upon release, contains recommendations for clinical laboratories and commercial manufacturers regarding development of diagnostic tests for COVID-19 during the current public health emergency.

To read the full text of this Duane Morris Alert, please visit the firm website.

March 13, 2020September 1, 2020 by Duane Morris

In Wake of Coronavirus (COVID-19), USTR Implements New Section 301 Exclusions for Certain Medical Products

As concerns surrounding coronavirus (COVID-19) escalate, U.S. trade policy is aligning with the country’s medical needs. On March 10, 2020, the United States Trade Representative (USTR) announced new Section 301 exclusions for certain kinds of Chinese-origin medical products. Although the USTR previously levied Section 301 duties as high as 15 percent against these products, the announced exclusions exempt them from Section 301 duties until September 1, 2020. Significantly, the new exclusions are retroactive in nature so that entities can seek refunds of the Section 301 duties that they have paid on the excluded products dating back to September 1, 2019. Assuming the USTR continues prior procedures, it is expected that the importing community will be allowed to submit written comments to support extensions of the exclusions.

To read the full text of this Duane Morris Alert, please visit the firm website.

March 12, 2020August 31, 2020 by Duane Morris

In Response to COVID-19, FDA Postpones Foreign Inspections Through April

FDA announced on March 10, 2020, that the agency is postponing most foreign inspections through April, effective immediately. FDA will consider whether to conduct inspections outside the U.S. deemed mission-critical on a case-by-case basis.

Postponing foreign inspection will likely delay product application reviews that require facility inspections. FDA has committed to trying to mitigate any potential impact that the COVID-19 outbreak and suspension of foreign inspections may have regarding FDA action on product applications. The extent of that impact will likely depend on how soon foreign inspections can resume and the resources, including personnel, available to FDA once they resume.

To read the full text of this Duane Morris Alert, please visit the firm website.