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

Pre-NDA Meeting NDA Submissions

PDG has participated in multiple NDAs (505(b)(1) and 505(b)(2)) and sNDAs, including first-in-class drug products, new chemical entities, Rx-to-OTC switches, and fixed-dose combinations.

Regardless of the scope of the program, experience has taught us that communication and planning is critical at the outset of 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 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 FDA minutes are understood and agreed upon, PDG will compile and submit your NDA, including:

  • Review, tabulate and summarize 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 labeling
  • Proposed launch materials
  • Parallel tracks for integrated launch preparations
print