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« Back to: US Regulatory References

Key Acts & Statutes

Federal Food, Drug and Cosmetic Act

Public Health Service Act

Prescription Drug User Fee Act

  • 1997PDUFA II 
    • expanded the goals to include activities related to the investigational phases of a new drug's development and it also added the goal of increasing FDA communications with industry and consumer groups.
  • 2002PDUFA III : Enhancements to FDA review process
  • 2007PDUFA IV