WK72293 - New Guide for Standard Guide for Definition of Combination Products (Drug / Device / Biologic Combinations)

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 Combinations

Rationale

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.

Details

Developed by Subcommittee: E55.91

Committee: E55

Staff Manager: Travis Murdock

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

New Guide for Standard Guide for Definition of Combination Products (Drug / Device / Biologic Combinations)

1. Scope

Keywords

Rationale

Details

Work Item Status

Related

New Guide for Standard Guide for Definition of Combination Products (Drug / Device / Biologic Combinations)

1. Scope

Keywords

Rationale

Details

Work Item Status

Related