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FDA Tightens the Rules for Antibody (Serology) Test Manufacturers

Client Alert | 1 min read | 05.05.20

EDIT The U.S. Food and Drug Administration (FDA) walked back its policy that allowed COVID-19 antibody test kits to enter the market without agency review. In its original March 16 Final Guidance, FDA allowed commercial manufacturers to market and sell antibody test kits after internally validating their own products and notifying FDA. The Agency did not require emergency use authorization (EUA) as it did with PCR (molecular) testing, though seeking an EUA was “encouraged.”

The updated Final Guidance requires manufacturers to submit a completed EUA request within ten business days of notification to FDA that the assay has been successfully validated, or the date of publication of the guidance, whichever is later. This requirement applies even to already-marketed tests that did not previously receive EUAs. The Guidance states that if FDA becomes aware of questions or concerns about a test after notification, such as poor performance or misleading statements about the test, FDA will communicate those concerns to the manufacturer and provide the manufacturer an opportunity to address the questions or concerns. If the concerns cannot be or have not been addressed in a timely manner, and the manufacturer has already distributed the test, FDA would expect the manufacturer to suspend distribution of the test.

Appendix A to the Guidance offers a template for manufacturers’ submissions to FDA. The Appendix states that the clinical agreement data should be provided using at least 30 antibody positive samples for each immunoglobulin claimed and 75 antibody negative samples. The test should demonstrate a minimum overall 90.0% positive percent agreement and overall 95.0% negative percent agreement. In other words, tests should be able to accurately detect at least 90% of positive patients and produce false positives less than 5% of the time.

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Client Alert | 3 min read | 03.28.24

UK Government Seeks to Loosen Third Party Litigation Funding Regulation

On 19 March 2024, the Government followed through on a promise from the Ministry of Justice to introduce draft legislation to reverse the effect of  R (on the application of PACCAR Inc & Ors) v Competition Appeal Tribunal & Ors [2023] UKSC 28.  The effect of this ruling was discussed in our prior alert and follow on commentary discussing its effect on group competition litigation and initial government reform proposals. Should the bill pass, agreements to provide third party funding to litigation or advocacy services in England will no longer be required to comply with the Damages-Based Agreements Regulations 2013 (“DBA Regulations”) to be enforceable....