WHAT: Formal Review of scientific and/or medical disputes. Related to applications for user fee products.  To quickly and impartially investigate complaints and resolve disputes between CDER and CDER-regulated industry, health care practitioners, and consumers by offering an informal, confidential, and neutral environment

HOW: Process codified in Code of Federal Regulations (CFR) and  CDER/CBER Guidance for Industry

WHO:  FDA contacts:

  • CDER Formal Dispute Resolution Project Manager
  • Ombudsman





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