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BioWorld - Thursday, March 23, 2023
Home » Topics » Regulatory

Regulatory
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FDA’s Stenzel says standards for molecular tests for SARS-CoV-2 a good approximation for NGS testing

June 3, 2020
By Mark McCarty
No Comments
The latest U.S. FDA town hall for testing for the COVID-19 included a few updates on serological testing, but perhaps the most important take-away was when Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiology, advised attendees that performance expectations regarding next-generation sequence (NGS) testing for the SARS-CoV-2 virus will closely resemble those of conventional molecular testing.
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Cpass test kit components

Genscript seeks EUA for test that indicates immunity to COVID-19

June 3, 2020
By Meg Bryant
No Comments
As more COVID-19 antibody testing becomes available, one question has been on everybody’s mind: Does the presence of antibodies to SARS-CoV-2, the virus responsible for the global pandemic, mean that people are protected from future infection? To that end, Genscript Biotech Corp., of Piscataway, N.J., has applied for emergency use authorization (EUA) with the U.S. FDA to market a test that specifically recognizes neutralizing antibodies to SARS-CoV-2.
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Regulatory front for June 3, 2020

June 3, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for June 3, 2020

June 3, 2020
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Fractyl, Surgical Information Sciences.
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Regulatory front for June 3, 2020

June 3, 2020
No Comments
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for June 3, 2020

June 3, 2020
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Clarity, FSD, Genmab, Novartis, Pierre Fabre, Revive, Specialised Therapeutics, Treadwell, Trevena.
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Researcher in PPE looking at three vials

WHO launches COVID-19 patent pool, backed by 35+ countries

June 2, 2020
By Nuala Moran
No Comments
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
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Regulatory front for June 2, 2020

June 2, 2020
No Comments
The latest global regulatory news, changes and updates affecting biopharma, including: Blue Dog Coalition, FDA, U.S. House and Senate.
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Memed secures CE mark for new POC blood test

June 2, 2020
By Nuala Moran
No Comments
LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.
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Regulatory front for June 2, 2020

June 2, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Rewalk Robotics.
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