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505(b)(2) – Part 2: The Assessment: Clinical Development Plan

Clinical Development PlanThe proposed Clinical Development Plan is dependent on the selected regulatory pathway.  The Clinical Development Plan is based on available Agency study recommendations provided in the FDA Guidance for Industry documents, information in the public domain (e.g., PubMed), and information obtained from SBA documents as applicable.

The plan consists of the outline of each study in sufficient detail to understand the potential cost, duration and risk of failure/success.  Typically, this information would include:

  • number of subjects (normal healthy or patients)
  • primary and secondary endpoints
  • treatments (doses) & duration of treatment
  • controls (e.g., RLD, placebo)
  • examinations (visits), evaluations & measurements

This information is input into the CMC plan to enable an estimation of the number of batches and timing of clinical trial material.  This information is also used to determine the regulatory timeline and cost;  the number and kind of submissions.

The study outline will be used as the basis for development of complete study protocols.