Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Biologics, Drugs, Medical Devices

Topics

Administrative / Procedural, Pediatric Product Development

Published

July 9, 2015

Last updated

April 11, 2024

Description

This document provides guidance for industry, researchers, patient groups, and FDA staff on meetings with the Office of Orphan Products Development.

Organization

Country / Region

United States

License

Other (Public Domain)

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