Work Item
ASTM WK72293

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

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, specifications, and performance standards for the manufacture of pharmaceutical and biopharmaceutical products. The Committee will encourage research in this field and sponsor symposia, workshops, and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

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.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: E55.03

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: Negative Votes Need Resolution