Kari Airenne’s Post

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A virus wrangler, turning villains to heroes | Gene Therapy | Research and Development | Protein Engineering and Production | Project Leadership and Management

FDA has released a draft guidance titled “Platform Technology Designation Program for Drug Development” (https://lnkd.in/dSyWGUY4), aimed at accelerating future drug applications for subsequent treatments derived from the same platform technology. A platform technology is defined as a well-understood and reproducible technology, which may include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or a combination of these technologies. This can ease gene therapy regulatory burden and speed up next generation therapies. #FDA #GeneTherapy #Regulation #Guidance https://lnkd.in/d57D_r73

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