FDARA and FDA User Fee Programs

President signed into law the Food and Drug Administration Reauthorization Act (FDARA)

  • Revises and extends FDA’s user-fee programs for prescription drugs (PDUFA), medical devices (MDUFA), generic drugs (GDUFA) and biosimilar (BsUFA) products
  • Provides FDA resources for increasing regulatory efficiency and expedite availability of innovative, safe and effective medical products
  • Read how FDARA is making a difference

Drug User Fees


Medical Device User Fees





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