Work Item
ASTM WK72293
New Guide for Standard Guide for Definition of Combination Products (Drug / Device / Biologic Combinations)
1. Scope
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.Keywords
Combination Product; Combo Product; Mode of Action; PMOA; Biologic CombinationsRationale
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.
Work Item Status
Date Initiated: 03-16-2020
Technical Contact: Manfred Maeder
Item: 001
Ballot: E55.03 (22-01)
Status: Will Reballot Item
Item: 004
Ballot: E55 (22-05)
Status: Will Reballot Item
Item: 002
Ballot: E55 (23-02)
Status: Will Reballot Item
Item: 003
Ballot: E55 (23-05)
Status: Will Reballot Item