AdvaMed Statement on the Release of FDA Rule on Laboratory-Developed Tests

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WASHINGTON, D.C. –  Today, AdvaMed, the Medtech Association, released the following statements from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s final rule for Laboratory Developed Tests (LDTs):

“We appreciate FDA’s commitment to ensuring the safety and effectiveness of in vitro diagnostic tests, regardless of their source, which is what today’s rule would accomplish,” Whitaker said. “We hope this rule is just the first step toward comprehensive reform of the framework for diagnostic test regulation overall, which the VALID Act would accomplish through Congress. This reform is critical to supporting the continued innovation of safe, effective, and high-quality diagnostic tests.”

“This rule represents significant progress in ensuring that diagnostic tests, regardless of where they were developed, meet FDA’s rigorous standards for safety and effectiveness,” Rothstein said. “We also encourage Congress to pass the bipartisan VALID Act, which would establish a modernized, diagnostics-specific regulatory framework for all diagnostics tests. We remain committed to advocating for this important legislation and we look forward to continuing our collaboration with Congress and all stakeholders in these efforts.”

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Georgia Life Sciences Designates Paulding County as Newest BioReady® Silver Community

January 20, 2026
January 20, 2026. Paulding County has been designated a BioReady Silver Community by Georgia Life Sciences, the state’s leading life sciences membership organization. The BioReady designation recognizes communities that demonstrate strong zoning practices, infrastructure capacity, and readiness to support biotechnology and life sciences development. “We are proud to recognize Paulding County as our newest BioReady Silver community,” said Maria Thacker-Goethe, President and CEO of Georgia Life Sciences. “Paulding County’s proactive planning, growing workforce, and access to regional healthcare and transportation infrastructure position it well to support life sciences manufacturing and commercialization. Through the BioReady program, we champion communities that are intentionally preparing to compete for industry investment and job growth.” Paulding County’s designation reflects its commitment to thoughtful land-use planning, scalable infrastructure, and business-friendly development policies that support life sciences and advanced manufacturing uses. Located in the northwest Atlanta metro region, the county offers access to a strong labor pool, major transportation corridors, and regional healthcare systems, making it an attractive option for biotechnology, medical device, diagnostics, and related life sciences companies seeking room to grow. “Georgia BioReady designation validates Paulding County’s readiness to support bioscience investment and strengthens our position as a growing hub for advanced industries,” said Alex Almodovar, President & CEO, Paulding County Economic Development Inc. & Industrial Building Authority The BioReady rating system evaluates communities across three tiers—Bronze, Silver, and Gold—based on their readiness to attract and support life sciences facilities. Through these ratings, Georgia Life Sciences helps municipalities better showcase biotech-appropriate sites, strengthen infrastructure planning, and clearly identify life sciences-friendly locations. This approach enables communities like Paulding County to compete more effectively for private investment and high-quality job creation. Georgia Life Sciences advances innovation, strengthens the workforce pipeline, and grows Georgia’s life sciences economy through the BioReady Community program, modeled after MassBio’s nationally recognized rating system, which assesses a community’s readiness to host life sciences facilities based on zoning practices and infrastructure capacity. About Georgia Life Sciences Georgia Life Sciences, founded in 1989, is a non-profit, membership-based organization that promotes the interests and growth of the life sciences industry. It is the state’s largest and most influential life sciences advocacy and business leadership organization working to improve access to innovative discoveries that have lifesaving impact. The association connects business, academia, government, and other allied entities involved in the application of life sciences products to fuel growth and collaboration through policy development, community programs, national industry initiatives, and a portfolio of educational and networking events. Learn more at galifesciences.org.

StandTogether | Georgia Life Sciences Institute - EPIC

January 14, 2026
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America's Biotech Leadership Depends on the States

January 8, 2026
By: Patrick Plues | RealClearHealth January 8, 2026 For decades, America has led the global biotech industry – thanks, in part, to state-level policies that encourage research and manufacturing investments. But other countries, including China, are sparing no expense in the bid to overtake us. Beijing has officially made biotechnology a national strategic priority and is pouring billions into state-backed research and manufacturing efforts. All states should consider impactful biotech policies that grow and strengthen our domestic biotechnology industry. If states fail to utilize and replicate what are considered to be the best and most successful policies in biotech-focused economic development, the United States will soon lose its long-term leadership in developing medicines and medical technologies, which underpin our health, our economy, and our national security. Thankfully, many governors and state legislatures around the country are already answering this call -- as our new study, The U.S. Bioscience Industry: A Powerful Engine for State Economies, demonstrates. Keep Reading at https://www.realclearhealth.com/2026/01/08/americas_biotech_leadership_depends_on_the_states_1157584.html
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