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Drug Approval Package: Onpattro (patisiran) (US FDA, 2018); https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210922Orig1s000TOC.cfm. The drug approval package for Onpattro—an LNP approved by the US FDA for commercial use, and the only one via the NDA pathway.
Summary Basis for Regulatory Action: Comirnaty (US FDA, 2021); https://www.fda.gov/media/151733/download. The summary basis of approval for Comirnaty—the second LNP approved (via emergency-use authorization) by the US FDA for commercial use, this time via 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/download
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Spikevax (COVID-19 Vaccine, mRNA) Suspension for Injection, for Intramuscular Use [Package Insert] (US FDA, 2022); https://www.fda.gov/media/155675/download
Summary Basis for Regulatory Action: Spikevax (US FDA, 2022); https://www.fda.gov/media/155931/download. The summary basis of approval for Spikevax—the third LNP approved (via emergency-use authorization) by the US FDA for commercial use, and the second via the BLA pathway.
Committee for Medicinal Products for Human Use. COVID-19 Vaccine Moderna Assessment Report EMA/15689/2021 Corr.1 (EMA, 2021); https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
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Guideline for the Development of Liposome Drug Products (Japan Ministry of Health, 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 Products (Japan Ministry of Health, Labour and Welfare, 2016); https://www.nihs.go.jp/drug/section4/160328_MHLW_siRNA_RP.pdf
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