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Episode Synopsis
ReferencesPolicy & 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 CommitteeFDA: Development & Approval ProcessPhrma Org: "Biopharmaceutical Research & Development"CMU Alumni Association Video: COVID-19, mRNA and the Future of VaccinesInternational 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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