List of Open-Source in New Drug Applications NDAs FDA. Compiled for reserarch for conference talk. Feel free to send me more if I missed any. R at top and python is below. Oldest date for R is 2007.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217188Orig1s000IntegratedR.pdf 2023 Pfizer, Inc. "Source: adex.xpt and adsl.xpt; Software: R"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/050708Orig1s053;%20050709Orig1s045;%20210115Orig1s005.pdf 2021 Astellas Pharma US, Inc. "FDA Response to Question 3c: We agree with the program submission using R markdown."
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761289Orig1s000MultidisciplineR.pdf 2022 AstraZeneca AB (Sweden) "Source:az‐durvalumab‐pk‐model‐himalaya‐V1.0.Rmd"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/212608Orig1s006.pdf 2021 Blueprint Medicines Corporation "“Population_PK_Review_Template_NDA212608” ".rmd and .docx files" "R markdown code and .docx output for analyzing popPK dataset, popPK model, E-R safety dataset, and E-R efficacy dataset; code for Table 3, Table 6, Table 7, Table 12, Figure 5, Figure 6, Figure 7, Figure 8, Figure 31, and Figure 32."
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217369Orig2s000IntegratedR.pdf 2023 Sage Therapeutics "Source: Study PPD-301 adae.xpt; Software: R"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761286Orig1s000IntegratedR.pdf 2023 UCB, Inc "Source: adex.xpt and adsl.xpt; Software: R and MG0003 CSR Table 6.2.2" "Primary analysis and plotting were performed in R 4.1.2."
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/202293Orig1s026.pdf 2023 AstraZeneca Pharmaceuticals LP "Source: Reviewer’s analysis [adsl, adex]; Software: R" "Source: Reviewer’s analysis [adsl, adae, adce, adtte]; Software: R" "The statistical software R was used for safety analyses."
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215341Orig1s000IntegratedR.pdf 2021 Bayer Healthcare Pharmaceuticals "Source: adsl.xpt; Software: R" "Source: adae.xpt; Software: Python"
https://www.fda.gov/media/168215/download 2023 Intercept Pharmaceuticals *FDA Briefing Document for NDA 212833 "Source: Clinical data Scientist’s analysis of adae.xpt; Software: R (Ver 4.1.0)"
https://www.fda.gov/media/164666/download 2023 Cidara Therapeutics, Inc. *FDA Briefing Document for NDA #217417 "Source: adae.xpt; software: R"
https://www.fda.gov/media/172242/download 2023 Intarcia Therapeutics, Inc. *FDA Briefing Document for NDA #209053 "Source: CDER Review staff. Software: R v. 4.2 (IVC_plots.R);" "Source: CDER Review staff. Analysis: R v. 4.3, survival package (Therneau and Grambsch 2000; Therneau 2023)."
https://www.fda.gov/media/165980/download 2023 Merck Sharp & Dohme Corp. *Statistical Review - Vaccine "I have independently verified the results related to the non-stratified analysis using BinomDiffCI function of DescTools package of the R software. I verified the stratified MN confidence interval using the scoreci function of the ratesci package in R. The summary of results is provided in Table 8"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209279Orig1s000MedR.pdf Actelion 2017 "Source: Efficacy.Rmd." "R code for all analyses and graphs."
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000StatR.pdf 2015 Actelion Pharmaceiticals
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000StatR.pdf 2013 Vanda Pharmaceuticals
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205755orig1s000clinpharmr.pdf 2014 Novartis
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202611Orig1s000StatR.pdf 2011 Astellas Pharma
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207988Orig1s000StatR.pdf 2014 Ardea Biosciences
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202806orig1s000clinpharmr.pdf 2013 GlaxoSmithKline “The statistical software R (www.r-project.org) and S-plus (Tibco, Palo Alto, CA) were used to generate all plots.“
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208573Orig1s000ClinPharmR.pdf 2015 AbbVie "The statistical software R (version 3.05) and SAS (version 9.3) was used for statistical and graphical"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211964Orig1s000IntegratedR.pdf 2021 Supernus Pharmaceuticals “Source: adds.xpt; Software, R. Table created by the Clinical Data Scientist.”
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203188Orig1s000StatR.pdf 2012 Vertex
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022129s000_StatR.pdf 2007 Summer’s Laboratories
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202022Orig1s000ClinPharmR.pdf 2011 Diagnosticgraphs, model comparison, and statistical analysis were performed in R Tibotec
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209241oirg1s000clinpharmr.pdf 2016 Neurocrine Biosciences, Inc. "The statistical software R (version 3.3.1) were utilized for dataset compilation, analyses and generation of plots."
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213217Orig1s000MultidisciplineR.pdf 2020 BeiGene "The statistical software R was utilized to generate review plots and summarize potential confounders by exposure group"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761044Orig1s003.pdf 2019 JNJ "The statistical software R was utilized to generate the summary of potential confounders by exposure group."
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214103Orig1s000IntegratedR.pdf 2020 Alnylam Pharmaceuticals Source: adds.xpt and Clinical Study Report; Software: R.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761210Orig1s000MultidisciplineR.pdf 2020 Janssen Biotech "outputs were performed using statistical software R (version 3.4.1 or later)"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214916Orig1s000MultidisciplineR.pdf 2021 Cara Therapeutics, Inc. "outputs were performed using statistical software R (version 3.6.2 or later)"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214985Orig1s000IntegratedR.pdf 2022 Idorsia "Source: adds.xpt and Clinical Study Report; Software: R,"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209296Orig1s000ClinPharmR.pdf 2017 Heron Therapeutics "AUC0-inf was calculated using R package (“PK”) based on the last four plasma concentrations"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209510Orig1s000MultidisciplineR.pdf 2020 Acacia Pharma Ltd "The simulations and all subsequent calculations were performed using R (version 3.2.3 (2015- 11-30), The R Foundation for Statistical Computing, Platform: x86 64-pc-linux-gnu (64-bit)) and R-Studio (version 1.1.442 2009-2018 RStudio, Inc.)"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761178Orig1s000ClinPharm_Redacted.pdf 2020 Biogen, Inc. "Non-linear mixed effects software NONMEM (version 7.3) and R Studio (version 1.2.5033) were used for dataset compilation, analyses and generation of plots"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761069Orig1s000ClinPharmR.pdf 2016 Astrazeneca "All data processing and analyses were performed using R version 3.2.2 under R studio"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/Seife%20Production_2017_09_29%20Part%202_Redacted.pdf 2016 Serepta "All analyses were done using SAS® (Version 9.3) and R Studio (Version 0.97.551)"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210795Orig1s000MultidisciplineR.pdf GSK 2018 Page 210
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203093Orig1s000ClinPharmR.pdf 2012 Gilead Sciences "Rstudio/R 2.14.0 were used for data manipulation and analysis"
https://www.fda.gov/media/168215/download 2023 *FDA Briefing Document NDA# 212833 Intercept Pharmaceuticals "Source: FDA Review staff analysis using Applicant-submitted data adsl.xpt, adlbce.xpt, adlbhb.xpt, adcm.xpt, adexsum.xpt in Python (Ver. 3)"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214410Orig1s000,%20210854Orig1s004,%20s010IntegratedR.pdf 2020 Genentech, Inc. "Source: adae.xpt; Software: Python"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761194Orig1s000IntegratedR.pdf 2021 Genzyme Corporation "Source: adsl.xpt; Software: Python"
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215498Orig1s000IntegratedR.pdf 2021 Albireo AB "Source: Generated by CDS; adae.xpt; Software: Python;"
https://cran.r-project.org/web/packages/adaptIVPT/index.html 2024-01-26 Package provides procedures based on parallel replicate design and balanced data, according to the U.S. Food and Drug Administration's "Draft Guidance on Acyclovir" https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_topical%20cream_RLD%2021478_RV12-16.pdf Maintained by FDA
https://www.fda.gov/media/172331/download 2023 FDA Introductory Remarks Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting September 21, 2023 ITCA 650 (exenatide in DUROS) 2023 "Source: CDER Review staff; software: R v. 4.2; Data: adsl.xpt (SDN0000) and subject listings from other CVOTs"
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-kerendia 2021 Bayer Healthcare Pharmaceuticals Inc. "Source: adsl.xpt and adae.xpt; Software: R"
https://covid19crc.org/wp-content/uploads/2020/09/mRNA-1273-P301-Protocol-2020.pdf 2020 Moderna "Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older The sample size is calculated using R package gsDesign (Anderson 2020)"
https://www.accessdata.fda.gov/CDRH510K/K102973.pdf 2011 References research done in R 90(2):203-208, 2011 "The assignments were generated by the project statistician, using the “sample” function of R statistical software (Version 2.7.1, The R Foundation for Statistical Computing, 2008)."
https://www.cdc.gov/mmwr/volumes/72/wr/mm7220a3.htm 2023 JYNNEOS Vaccine "Analyses were conducted using the survival package in R statistical software (version 4.2.2; The R Foundation)."
https://www.fda.gov/food/laboratory-methods-food/bam-appendix-2-most-probable-number-serial-dilutions 2023 https://cran.r-project.org/web/packages/MPN/index.html
https://www.fda.gov/medical-devices/science-and-research-medical-devices/imrmc-software-do-multi-reader-multi-case-statistical-analysis-reader-studies "perform a noninferiority study using the iMRMC R package" https://github.com/DIDSR/iMRMC