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Home » FDA Rejects Monograph as a Solution for Unapproved Drugs
FDA Rejects Monograph as a Solution for Unapproved Drugs
February 5, 2007
The FDA is rejecting the notion that it should allow unapproved prescription drugs that meet category-wide safety and efficacy standards to be approved for marketing, arguing that the risks are too great and that the approach is too expensive and time-consuming.