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Abstract Foundation for Regulatory Motion: Comirnaty (US FDA, 2021); https://www.fda.gov/media/151733/obtain. The abstract foundation of approval for Comirnaty—the second LNP permitted (by way of emergency-use authorization) by the US FDA for business use, this time by way of the BLA pathway.
Comirnaty (COVID-19 Vaccine, mRNA) Suspension for Injection, for Intramuscular Use [Package Insert] (US FDA, 2021); https://www.fda.gov/media/151707/obtain
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Abstract Foundation for Regulatory Motion: Spikevax (US FDA, 2022); https://www.fda.gov/media/155931/obtain. The abstract foundation of approval for Spikevax—the third LNP permitted (by way of emergency-use authorization) by the US FDA for business use, and the second by way of the BLA pathway.
Committee for Medicinal Merchandise for Human Use. COVID-19 Vaccine Moderna Evaluation Report EMA/15689/2021 Corr.1 (EMA, 2021); https://www.ema.europa.eu/en/paperwork/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
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Steering for Trade: Drug Merchandise, Together with Organic Merchandise, that Include Nanomaterials (US FDA, 2022); https://www.fda.gov/media/157812/obtain
Guideline for the Growth of Liposome Drug Merchandise (Japan Ministry of Well being, Labour and Welfare, 2016); https://www.nihs.go.jp/drug/section4/160328_MHLW_liposome_guideline.pdf
Reflection Paper on Nucleic Acids (siRNA)-loaded Nanotechnology-based Drug Merchandise (Japan Ministry of Well being, Labour and Welfare, 2016); https://www.nihs.go.jp/drug/section4/160328_MHLW_siRNA_RP.pdf
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