Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Combination Products
Published
April 21, 2020
Last updated
April 21, 2020
Description
A draft guidance document discussing technical considerations for demonstrating reliability of emergency-use injectors submitted under BLA, NDA, or ANDA.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)