FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Premarket
Published
October 3, 2022
Last updated
October 6, 2022
Description
This document provides guidance for the FDA and industry on the impact of premarket approval applications on review timelines and goals.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)