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root cause analysis reports, data collection, personal FDA nodes, and…
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# 📖 References

* [Google Spreadsheet of FDA Spending vs Life-Expectancy](https://docs.google.com/spreadsheets/d/e/2PACX-1vTBkVrOYLxloOIADLXA7-k5NBIGgQ\_dfFQ7BLUN0oaJPVQ\_NqdFdVUfhuPkVWgFZ9gfLrwPdjuG1sTn/pubhtml)
* [Summary of NDA Approvals & Receipts, 1938 to the present](https://www.fda.gov/about-fda/histories-product-regulation/summary-nda-approvals-receipts-1938-present)
* [Theory, Evidence, and Examples of FDA Harm](https://www.fdareview.org/issues/theory-evidence-and-examples-of-fda-harm/)
* [DATA](https://docs.google.com/spreadsheets/d/1hltgVd8OO\_nfd9m7FUbbsOTXFX4VbDKuFNw4Cy43f7Q/edit#gid=0)
* [GDP](https://ourworldindata.org/economic-growth)
* [Reform, Regulation, and Pharmaceuticals — The Kefauver–Harris Amendments at 50](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4101807/)
* [Consumer Price Index](https://www.bls.gov/regions/midwest/data/consumerpriceindexhistorical\_us\_table.pdf)
* [Estimates of World GDP, One Million B.C. – Present](https://delong.typepad.com/print/20061012\_LRWGDP.pdf)
* [Newspaper Generator](https://newspaper.jaguarpaw.co.uk/)
* [Report suggests drug-approval rate now just 1-in-10](https://www.amplion.com/report-suggests-drug-approval-rate-now-just-1-in-10/)
* [How many people die and how many are born each year?](https://ourworldindata.org/births-and-deaths)
* [Gross World Product per capita](http://statisticstimes.com/economy/gross-world-product-capita.php)
* [History of Clinical Trials](https://en.wikipedia.org/wiki/Clinical\_trial#History)
* [How many life-years have new drugs saved?](https://academic.oup.com/inthealth/article/11/5/403/5420236)
* [CATO](https://www.cato.org/publications/commentary/end-fda-drug-monopoly-let-patients-choose-their-medicines)
* [Medical Innovation](http://valueofinnovation.org/)
* [Timeline History of Clinical Research](https://www.timetoast.com/timelines/history-of-clinical-research)
* [FDA and Clinical Drug Trials: A Short History](https://www.fda.gov/media/110437/download)
* [Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements?](https://www.independent.org/publications/article.asp?id=1302)
* [Reform Options](https://www.fdareview.org/issues/reform-options/)
* [Before Occupy: How AIDS Activists Seized Control of the FDA in 1988](https://www.theatlantic.com/health/archive/2011/12/before-occupy-how-aids-activists-seized-control-of-the-fda-in-1988/249302/)
* [A Brief History of the Center for Drug Evaluation and Research](https://www.fda.gov/about-fda/virtual-exhibits-fda-history/brief-history-center-drug-evaluation-and-research#display\_58)
* [Milestones in U.S. Food and Drug Law History](https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/milestones-us-food-and-drug-law-history)
* https://go.drugbank.com/stats

Additional Sources

1. https://www.ahajournals.org/doi/10.1161/strokeaha.111.621904
2. https://www.fda.gov/media/110437/download
3. https://www.academia.edu/2801726/Is\_the\_FDA\_safe\_and\_effective
4. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
5. https://www.cato.org/commentary/end-fda-drug-monopoly-let-patients-choose-their-medicines
6. https://www.fda.gov/files/about%20fda/published/The-Sulfanilamide-Disaster.pdf
7. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
8. https://www.fda.gov/media/79922/download
9. https://www.fda.gov/media/120060/download
10. https://www.nature.com/articles/549445a
11. https://www.statista.com/statistics/1041467/life-expectancy-switzerland-all-time/
12. https://www.statista.com/statistics/195950/infant-mortality-rate-in-the-united-states-since-1990/
13. https://kof.ethz.ch/en/news-and-events/kof-bulletin/kof-bulletin/2021/07/Improvements-in-Swiss-life-expectancy-and-length-of-life-inequality-since-the-1870s.html
14. https://docs.google.com/spreadsheets/d/1hltgVd8OO\_nfd9m7FUbbsOTXFX4VbDKuFNw4Cy43f7Q/edit#gid=802845894
15. https://www.visualcapitalist.com/which-rare-diseases-are-the-most-common/
16. http://valueofinnovation.org/
17. https://www.medicinesaustralia.com.au/wp-content/uploads/2020/11/Prof-Frank-Lichtenberg\_session-3.pdf
18. Anglemyer A., Horvath H.T., and Bero, L. (2014). Healthcare Outcomes Assessed with Observational Study Designs Compared with Those Assessed in Randomized Trials (Review), Cochrane Database of Systematic Reviews, Issue 4, Art No MR000034. doi:10.1002/14651858.MR000034.pub2.
19. Ball, R., Robb, M., Anderson, S.A., and Dal Pan, G. (2016). The FDA’s Sentinel Initiative—A Comprehensive Approach to Medical Product Surveillance, Clinical Pharmacology & Therapeutics, 99(3):265-268. doi:10.1002/cpt.320. Benson, K. and Hartz, A.J. (2000). A Comparison of Observational Studies and Randomized, Controlled Trials, New England Journal of Medicine, 342:1878-1886. doi:10.1056/NEJM200006223422506.
20. Berger, M.J, Sox, H., Willke, R.J., Brixner, D.L., Hans-Georg, E., Goettsch, W., Madigan, D., Makady, A., Schneeweiss, S., Tarricone, R., Wang, S.V., Watkins, J., and Mullins, C.D. (2017). Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making, Pharmacoepidemiology and Drug Safety, 26(9):1033- 1039. doi:10.1002/pds.4297.
21. Clinical Trial Transformation Initiative (CTTI) (2017). CTTI Recommendations: Registry Trials. Retrieved from https://www.ctti-clinicaltrials.org/files/recommendations/registrytrials-recs.pdf.
22. Cooper, C.J., Murphy, T.P., Cutlip, D.E., Jamerson, K., Henrich, W., Reid, D.M., Cohen, D.J., Matsumoto, A.H., Steffes, M., Jaff, M.R., Prince, M.R., Lewis, E.F., Tuttle, K.R., Shapiro, J.I., Rundback, J.H., Massaro, J.M., D’Agostino, R.B., and Dworkin, L.D. (2014). Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis, New England Journal of Medicine, 370(1):13-22. doi:10.1056/NEJMoa1310753.
23. Eapen, Z.J., Lauer, M., and Temple, R.J. (2014). The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials. Journal of the American Medical Association, 311(14): 1397-1398. doi:10.1001/jama.2014.1030. Eworuke, E. (2017). Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year Risk of Seizures Associated with Ranolazine \[Power Point Presentation]. Retrieved from https://www.sentinelinitiative. org/sites/default/files/communications/publications-presentations/Sentinel-ICPE-2017-Symposium-Snapshotof-the-First-Year\_Ranexa-Seizures.pdf.
24. Food and Drug Administration, Center for Medicare Services, and Acumen Team. (2018). Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices Meeting: Relative Effectiveness of Cell-cultured versus Egg-based Influenza Vaccines, 2017-18 \[Power Point Presentation]. Retrieved from https://www.cdc.gov/ vaccines/acip/meetings/downloads/slides-2018-06/flu-03-Lu-508.pdf. Ford, I. and Norrie, J. (2016). Pragmatic Trials. New England Journal of Medicine, 375:454-463. doi:10.1056/ NEJMra1510059.
25. Fralick, M., Kesselheim, A.S., Avorn, J., and Schneeweiss, S. (2018). Use of Health Care Databases to Support Supplemental Indications of Approved Medications, JAMA Internal Medicine, 178(1): 55-63. doi:10.1001/ jamainternmed.2017.3919
26. Franklin, J.M., and Schneeweiss, S. (2017). When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials, Clinical Pharmacology & Therapeutics, 102(6):924-933. doi:10.1002/cpt.857.
27. Fröbert, O., Lagerqvist, B., Olivecrona, G., Omerovic, E., Gudnason, T., Maeng, M., Aasa, M., Angerås, O., Calais, F., Danielewicz, M., Erlinge, D., Hellsten, L., Jensen, U., Johansson, A.C., Kåregren, A., Nilsson, J., Robertson, L., Sandhall, L., Sjögren, I., Östlund, O., Harnek, J., and James, S.K. (2013). Thrombus Aspiration during STSegment Elevation Myocardial Infarction, New England Journal of Medicine, 369:1587-1597. doi:10.1056/ NEJMoa1308789.
28. Guadino, M., Di Franco, A., Rahouma, M., Tam, D.Y., Iannaccone, M., Deb, S., D’Ascenzo, F., Abouarab, A.A., Girardi, L.N., Taggart, D.P., and Fremes, S.E. (2018). Unmeasured Confounders in Observational Studies Comparing Bilateral Versus Single Internal Thoracic Artery for Coronary Artery Bypass Grafting: A Meta-Analysis, Journal of the American Heart Association, 7:e008010. doi.org/10.1161/JAHA.117.008010.
29. Gliklich, R.E., Dreyer, N.A., and Leavy, M.B., editors. (2014). Registries for Evaluating Patient Outcomes: A User’s Guide \[Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. 1, Patient Registries. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK208643.
30. Hemkens, L.G., Contopoulos-Ioannidis, D.G., and Ioannidis, J.P. (2016). Agreement of Treatment Effects for Mortality from Routinely Collected Data and Subsequent Randomized Trials: Meta-Epidemiological Survey, BMJ, 352:i493. doi:10.1136/bmj.i493.
31. Hernandez, A.F., Fleurence, R.L., and Rothman, R.L. (2015). The ADAPTABLE Trial and PCORnet: Shining Light on a New Research Paradigm, Annals of Internal Medicine, 163(8):635-636. doi:10.7326/M15-1460.
32. Izurieta, H.S., Thadani, N., Shay, D.K., Lu, Y., Maurer, A., Foppa, I.M., Franks, R., Pratt, D., Forshee, R.A., MaCurdy, T., Worrall, C., Howery, A.E., and Kelman, J. (2015). Comparative Effectiveness of High-dose versus Standarddose Influenza Vaccines in US Residents Aged 65 Years and Older from 2012 to 2012 Using Medicare Data: a Retrospective Cohort, Lancet Infect Dis, 15(3):293-300. doi:10.1016/S1473-3099(14)71087-4.
33. Izurieta, H.S., Wernecke, M., Kelman, J., Wong, S., Forshee, R., Pratt, D., Lu, Y., Sun, Q., Jankosky, C., Krause, P., Worrall, C., MaCurdy, T., Harpaz, R. (2017). Effectiveness and Duration of Protection Provided by the Liveattenuated Herpes Zoster Vaccine in the Medicare Population Ages 65 Years and Older, Clinical Infectious Diseases, 64(6):785-793. doi.org/10.1093/cid/ciw854.
34. Khozin, S., Abernethy, A.P., Nussbaum, N.C., Zhi, J., Curtis, M.D., Tucker, M., Lee, S.E., Light, D.E., Gossai, A., Sorg, R.A., Torres, A.Z., Patel, P., Blumenthal, G.M., and Pazdur, R. (2018). Characteristics of Real-World Metastatic Non-small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval, Oncologist, 23(3): 328-336. doi: 10.1634/theoncologist.2017-0353.
35. Maggiono, A.P., Franzosi, M.G., Fresco, C., Turazza, F., and Tognoni, G. (1990). GISSI Trials in Acute Myocardial Infarction, CHEST Journal, 97(4), Supplement: 146S-150S. doi:10.1378/chest.97.4\_Supplement.146S
36. [Historical Changes in Causes of Death - Sociological Images (thesocietypages.org)](https://thesocietypages.org/socimages/2012/06/25/historical-changes-in-causes-of-death/)
37. [Causes of Death - Our World in Data](https://ourworldindata.org/causes-of-death)]
38. [NVSS - Mortality - Historical Data (cdc.gov)](https://www.cdc.gov/nchs/nvss/mortality\_historical\_data.htm)
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