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July 2023 FDA Watch

July 2023 FDA Watch

by Glenn S. Demby | Jul 5, 2023 | Essential, FDA-lir, Laboratory Industry Report

Key approvals announced in June represented important steps forward for the lab testing industry.

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The Diagnostics Pipeline: First FDA Approval of CRISPR Therapy Possible This Year

The Diagnostics Pipeline: First FDA Approval of CRISPR Therapy Possible This Year

by Glenn S. Demby | Jun 30, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.

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Expert Q&A: Expanding Beyond COVID-19 Testing

Expert Q&A: Expanding Beyond COVID-19 Testing

by Rachel Muenz | Jun 27, 2023 | Essential, Inside the Lab Industry-lir, Laboratory Industry Report

Gather Labs founder and CEO Rachael McCrary discusses how her lab has achieved success beyond COVID-19 testing.

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M&A & Strategic Deals: Dealmaking Shows New Signs of Life but FTC Scrutiny Casts a Dark Shadow

M&A & Strategic Deals: Dealmaking Shows New Signs of Life but FTC Scrutiny Casts a Dark Shadow

by Glenn S. Demby | Jun 1, 2023 | Essential, Industry Buzz-lir, Laboratory Industry Report

After a significant lull, M&As in the lab diagnostics space heated up in May, with several key deals announced.

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The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations

The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations

by Glenn S. Demby | Apr 24, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

On March 27, the agency released a new guidance document to help test developers make the transition to full approval.

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