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Timeline Estimates: Based on typical pharmaceutical development, if Eli Lilly started Phase 1 trials for oral tirzepatide today, FDA approval would likely be 5-7 years away at minimum
2 Of the 74 letters following on-site inspections, seven followed bioresearch monitoring (BIMO) inspections, 3 eight focused on human cell, tissue, or cellular products (HCTP), 4 two followed good laboratory practice (GLP) inspections, 5 nine were issued to pharmaceutical compounding firms, 6 and one was issued to a PET drug manufacturer
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More extensive rashes or hypersensitivity responses are uncommon but documented
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