This document was prepared by the National Health Council and Genetic Alliance with the intent of submission to the Food and Drug Administration to encourage adoption, wholly or in part, by the Agency.

Learning objectives

Objectives for the recommended language offered in this document: 1. Convey to the public that the Food and Drug Administration supports and encourages, but does not require, patient-focused drug development activities. 2. Provide definitions for the various terms used related to patient-focused drug development to encourage standardization.

Owner (organization)

National Health Council

Target audience

Pharmaceutical companies or industry , Other

Types

Guidance

Formats

PDF

Levels

Unknown

Language

English

Accessibility

Not applicable

Certification

No

Patients involved

No

Version date/number

01 Feb 2017

PFMD last access

28 Nov 2020

Organizations