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Study: Higher prices, more shortages after Unapproved Drugs Initiative

The FDA's Unapproved Drugs Initiative, which requires FDA approval of unapproved drugs already on the market, appears to have led to higher drug prices and more frequent drug shortages, and the approval process did not always require that sponsors conduct new clinical trials to establish safety or efficacy. Journal of Managed Care & Specialty Pharmacy (10/17)

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