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Single dose of mRNA-1345 vaccine safe, effective against RSV in seniors

Single dose of mRNA-1345 vaccine safe, effective against RSV in seniors
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The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps | King & Spalding

To embed, copy and paste the code into your website or blog: Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P manufacturers without an FDA-approved marketing application may find themselves subject to FDA scrutiny under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and the Public Health Service Act (“PHS Act”). Firms will have to think hard about whether to submit investigational new drug applications (“INDs”) or marketing applications, wind down production, or risk running afoul of applicable laws and regulations governing unapproved biological products. They should also be mindful of how data collected to date can help to inform next steps.

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The ISSCR releases updated guidelines for stem cell research and clinical translation

Scientists, research organizations, and scientific journals have long relied upon the ISSCR Guidelines as the international standard for scientific and ethical rigor, oversight, and transparency in stem cell research.

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Riga International Airport completes rapid-exit taxiway construction project

Riga International Airport completes rapid-exit taxiway construction project 12 May 2021 (Last Updated May 12th, 2021 09:54) The airport reconstructed a part of its runway and built a rapid-exit taxiway. Share Article With an aim to reduce carbon emissions, RIX started large-scale construction works in July last year. Credit: Avio2016 / Wikipedia. Riga International Airport (RIX) in Latvia has completed the construction of the second rapid-exit taxiway and the reconstruction of a portion of the runway. The taxiway has been constructed within the framework of the Cohesion Fund-funded project ‘Development of Safe and Environmentally Friendly Infrastructure at Riga International Airport.’ With an aim to reduce carbon emissions, the airport started large-scale construction works in July last year. The cost amounted to nearly $3.03m (€2.5m).

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