This episode analyzed how anticipated policy changes and regulatory reforms may impact the drug development landscape. Discussion on current debates, potential shifts, and strategic responses backed by recent examples were presented. Discussions on current policy standards are included and discussions about proposed regulatory shifts are also provided.

Among the areas covered are dietary supplements with new dietary ingredients. Rules for conducting clinical trials, and the Orphan Drug designation. Various pieces of literature from OPR&D were integrated into the discussion, as well as more information on how regulatory bodies could evolve in the future.