References

  • Policy & Medicine: "A Tough Road: Cost to Develop One New Drug is $2.6 Billion, Approval Rate for Drugs Entering Clinical Development is Less than 12%"
  • The Atlantic: "Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up"
  • MedicineNet: "Why Drugs Costs So Much"
  • Biopharma Dive: "New Estimate Puts Cost to Develop A New Drug at $1B, Adding to Long Running Debate"
  • Institutional Animal Care and Use Committee
  • FDA: Development & Approval Process
  • Phrma Org: "Biopharmaceutical Research & Development"
  • CMU Alumni Association Video: COVID-19, mRNA and the Future of Vaccines
  • International Coalition of Medicines Regulatory Authorities (ICMRA)
  • The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
  • Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) YouTube Video by the FDA

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