Show notes
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