Explore: Biological Licence Application (BLA) | Clinical Trial Application Dossier | Narratives | New Drug Application (NDA) | Pregnancy Prevention Plan (or Programme, PPP) | Product Information (PI) | Statistical Analysis Plan (SAP) | Summary of Product Characteristics (SmPC) | United States Prescribing Information (USPI)

New Drug Application (NDA)

  • An NDA is the request for marketing approval in the USA of a new drug (“an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or intended to affect the structure or any function of the body of man”).
  • Alternatively, an Abbreviated New Drug Application (ANDA) is the request for marketing approval of a generic drug – one based on a previously authorised reference drug.
  • The application includes relevant clinical trial results and the CTD documentation, as well as the Risk Evaluation and Mitigation Strategies (REMS) document.
  • Trilogy can advise on your documentation needs and offers the scientific expertise and industry experience required to provide the full range of documentation required for your submission.