The FDA seeks to provide scientifically and clinically valid guidance. They also seek to provide consistency, even in the face of rapidly advancing fields. The most common topics for which consensus has been determined are typically written up and publicly available as “FDA Guidance’s” or when harmonized internationally, “International Conference on Harmonization (ICH) Guidance Documents”.
Guidance documents represent the consensus viewpoints on what experiments to run, and how… and they’re freely available! They are absolutely required reading, spanning nonclinical safety studies, toxicology, ADME, CMC, clinical trial design, statistics, and much, much more.
Imagine the patient at one end of a chronological spectrum. At the other end is your product concept. When you’re ready to chart the path from patient back to product, these regulatory documents will provide much of the direction.
You must understand the consensus agreement on all regulatory topics of relevance to your product.
Understand the types of guidance’s available, and where to find them.