Request to change the definition of SubstanceDefinition.Representation.type to accommodate the FDA PQ/CMC requirement of supporting the methods used for substance characterization in eCTD M3.

Change definition —

FROM: The type of structure (e.g. Full, Partial, Representative).

TO: The kind of representation (e.g. full, partial) or the technique used to derive the analytical characterization of the substance (e.g. x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc.).