Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Combination Products
Published
May 3, 2004
Last updated
August 9, 2024
Description
This is a guidance document titled "Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product". It focuses on combination products.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)