Memorandum Elements. For your selected Subject Medical Product, you have been asked to prepare a memorandum (the Project P-VI/21C2A Memo) that: Describes the salient events in the D-D-C pathway followed by your Subject Medical Product. Identifies provisions of the PDUFA family of laws (i.e., PDUFA I through PDUFA V) and related regulations and guidances that facilitated or hindered your Subject Medical Product’s climb up the DDC Pathway. Describes how the PDUFA VI provisions (in their most recent form as of the date of your memo) would have facilitated or hindered the timing and substance of the DDC Pathway followed by your Subject Medical Product. Identifies regulations contemplated by the 21C2A that could have been helpful to expediting approval of your Selected Medical Product had they been in force at the time your Selected Medical Product was moving along the DDC Pathway.