2024
DOI: 10.3390/pharmaceutics16070918
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The United States Food and Drug Administration’s Platform Technology Designation to Expedite the Development of Drugs

Sarfaraz K. Niazi

Abstract: Drug development costs can be significantly reduced if proven “platform” technologies are allowed to be used without having to validate their use. The most recent US Food and Drug Administration (FDA) guideline brings more clarity, as well as a greater focus on the most complex technologies that can now be used for faster drug development. The FDA has highlights the use of lipid nanoparticles (LNPs) to package and deliver mRNA vaccines, gene therapy, and short (2–20 length) synthetic nucleotides (siRNA). Addit… Show more

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