Pre NDA Meeting and NDA Submission: 505(b)(1)/505(b)(2)

NDA and sNDA applications

PDG has participated in multiple new drug applications (NDA), (505(b)(1), 505(b)(2)), and supplemental new drug applications (sNDA), including first-in-class drug products, new chemical entities, prescription (Rx) to over-the-counter (OTC) switches, and fixed-dose combinations.

Regardless of the scope of the programme, experience has taught PDG that communication and planning is critical at the outset of US Food and Drug Administration (FDA) reviews.

For example, certain 505(b)(2)s may be submitted without the requirement of clinical studies. This means meeting with FDA early and often.

For a beneficial pre-NDA meeting, preparation is key

Upon completion of required studies (or literature in support of safety and efficacy), PDG will submit a pre-NDA meeting request, prepare a pre-NDA briefing package, and facilitate another meeting with the FDA on your behalf.

This meeting addresses the submission of the NDA including issues such as format and content, data presentations, methods of statistical analyses, electronic submission, the pediatric studies, whether standard or priority review, and other issues as needed.

Once these details are complete, and meeting minutes are understood and agreed upon, PDG will compile and submit your NDA, including:

  • Review, tabulate, and summarise pre-clinical and clinical literature
  • Clinical study reports
  • Integrated and linked data tables
  • Integrated summary of safety (ISS)
  • Integrated summary of effectiveness (ISE)
  • Toxicology and pharmacokinetic data
  • Chemistry manufacturing controls (CMC), scale-up for launch
  • Annotated labelling
  • Proposed launch materials
  • Parallel tracks for integrated launch preparations

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