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U.S. Department of Health and Human Services

For Industry

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GDUFA Federal Register Notices



  • Guidance For Industry: ANDA Submissions - Refuse-to-Receive Standards (RTR Standards guidance) (Final Guidance)
  • Guidance for Industry: ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits (Draft Guidance)
  • Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development; Request for Comments
  • Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers