COVID-19: Daily Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells

Hogan Lovells

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.

In Monday's report: FDA warns against unproven antibody tests, European Patent Office update, and a litigation update for Netherlands.

Monday, 22 June 2020

  • On Friday, 19 June, the U.S. Food and Drug Administration (FDA) wrote in a letter to clinical laboratory staff and health care providers that they should stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage. The FAQ lists commercial manufacturers of serological tests that had previously provided notification to FDA that they validated and intended to distribute a serology test, but that have now been removed from that notification list, and instead placed on the “removed” list online here. Presence on this new list may indicate that an EUA request was not submitted by the manufacturer within a reasonable period of time, or that significant problems were identified with the test that were not addressed in a timely manner, or that the manufacturer voluntarily withdraw their test notification. Along with this FAQ, the letter include details on why certain tests were added to the list, recommendations for how health care providers and clinical laboratories should handle tests that are still within their stock and to evaluate whether patients should be retested using an FDA-authorized test, and instructions for reporting problems with COVID-19 tests. (Authored by Randy Prebula)

  • The Hogan Lovells IP & Media Technology team is tracking the changes being made by intellectual property offices around the world in response to the coronavirus so we can keep you informed on the key developments. Online here is our latest update for the European Patent Office (EPO). (Authored by Imogen Fowler)

  • The Hogan Lovells IP & Media Technology team is closely following the impact of COVID-19 on the operation of Courts around the world and what this means in practice for clients engaged in or contemplating litigation, with respect to upcoming hearings, deadlines, and limitation periods. Online here is our latest update for Netherlands. (Authored by Katie McConnell)

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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