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Gene Therapies Make A Mark In US FDA Expedited Review Programs

 
• By Bridget Silverman

More than 20 gene therapies are being developed with increased interaction under FDA’s breakthrough and regenerative medicine programs. 

Researcher working with DNA on blurred background.

As the US FDA’s Center for Biologics Evaluation and Research braces for the coming wave of gene therapies, the agency has deemed at least 21 gene therapy products as breakthrough therapies or regenerative medicine advanced therapies, which offer valuable interactions with FDA during development to some of the most promising candidates.

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• By Sue Sutter

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Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

More from Pathways & Standards

Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says

 
• By Sue Sutter

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Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

 
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Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.