This Standard defines and gives examples of Combination Product presentations. This could include presentations such as combinations of Drug and Device and/or Biologics. The standard will define types of combination products at a high level.
Combination Product; Combo Product; Mode of Action; PMOA; Biologic Combinations
Currently, there are a variety of terminologies and definitions within different jurisdictions. This Standard Guide will serve as the global reference for Combination Products and related topics.
The title and scope are in draft form and are under development within this ASTM Committee.
Developed by Subcommittee: E55.03
Staff Manager: Travis Murdock
Date Initiated: 03-16-2020
Technical Contact: Manfred Maeder
Ballot: E55.03 (22-01)
Status: Will Reballot Item
Ballot: E55 (22-05)
Status: Negative Votes Need Resolution