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Home » GAO: FDA Should Announce Plans to Revise Product-Specific Guidances for NBCDs in Advance
GAO: FDA Should Announce Plans to Revise Product-Specific Guidances for NBCDs in Advance
The GAO called on the FDA to make its plans for publishing and revising guidance for nonbiological complex drugs (NBCDs) public, noting that sudden guidance changes cause a major expense for generics developers and can delay or prevent market entry of products.