FDA Science Board's Report: Legislative Negotiating Tactic, Or Just Whining For Money?
21st Century Cures criticized by FDA advisors for unfunded mandates, but legislation also represents best near-term prospect for reforms of the kind the report envisions.
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Agency documents its regulatory science accomplishments to advance product development and manufacturing and ensure the safety and effectiveness of marketed products.
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An FDA Science Board subcommittee report finds industry and researcher perceptions of FDA's science readiness has improved over the past eight years. But the agency still faces major challenges tied to the current speed of scientific and technical progress.