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Abstract

It is easy, in this modern age, to forget the fear and trepidation surrounding infectious disease that has ruled humanity from antiquity. Diseases that were epidemic such as flea-borne bubonic plague, as well as water-borne ailments including typhoid, mosquito-borne malaria, viral-borne small pox and polio were highly feared. Infections that occurred sporadically as endemic in nature included rabies, lockjaw, botulism, and anthrax and were terrifying prospects that could arise from relatively minor scrapes (a dog bite, stepping on a nail, eating contaminated food, or from breathing spores, respectively). Improved sanitation practices allowed people to avoid contracting many illnesses and, eventually, vaccination greatly reduced the worst microbial and viral diseases. By the turn of the twentieth century, the public began to expect that the federal government should provide regulation of food and drugs and otherwise contribute to the public welfare via legislation. In a reactionary manner, these regulatory efforts proceeded in fits and starts, usually as a counter to specific tragedies.

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Notes

  1. 1.

    Refers to Jung’s question: “Does the individual know that he is the makeweight that tips the scales?”.

  2. 2.

    Some references claim the vaccines were sent worldwide while others maintain that people were sent to Europe for treatment.

  3. 3.

    Vaccines in the Treatment of Disease, Page 239.

  4. 4.

    “It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.” Molecular Structure of Nucleic Acids, Watson and Crick, Nature, No. 4356, April 25, 1953.

  5. 5.

    Presumably aggregation of the viral particles/proteins would prevent the uniform application of the deactivating agent, formaldehyde.

  6. 6.

    The CDC’s Morbidity and Mortality Weekly Report.

  7. 7.

    https://www.hiv.gov/hiv-basics/overview/history/hiv-and-aids-timeline

  8. 8.

    PCP is Pneumocystis pneumonia.

  9. 9.

    https://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/100YearsofBiologicsRegulation/ ucm070022.htm

  10. 10.

    https://www.cdc.gov/prions/index.html

  11. 11.

    a mammal of the deer family (Cervidae).

  12. 12.

    https://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0459-gdl0001.pdf

  13. 13.

    https://www.ipqpubs.com/uncertainties-in-subvisible-particulates/

  14. 14.

    SVP is subvisible particle.

  15. 15.

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125338s000ltr.pdf

  16. 16.

    https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294orig1s000chemr.pdf

  17. 17.

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125390orig1s000ltr.pdf

  18. 18.

    “10. To characterize the types and amounts of subvisible particles in the drug product under stress conditions, at release, and throughout the dating period, and to propose an appropriate control strategy, based on the risk to product quality,” as per footnote [reference 15].

  19. 19.

    Do not confuse with Affymetrix, now a Thermo Fisher Scientific company.

  20. 20.

    type 258 (ST258), contains the carbapenemase gene.

  21. 21.

    “During the past 10 years there has been a steady decline in the number of antibiotics submitted for approval to the FDA, with only 2 new antibiotics approved in the past 2 years, and those approved have been analogs of previously approved classes of antibiotics.” Cross.

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Williams, K.L. (2019). Origins and Evolution of Drug Regulation. In: Williams, K. (eds) Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems. Springer, Cham. https://doi.org/10.1007/978-3-030-17148-3_2

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