Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Combination Products
Published
December 19, 2019
Last updated
July 6, 2020
Description
Draft guidance document for industry on bridging for drug-device and biologic-device combination products. Focuses on combination products.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)