FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Administrative / Procedural, Labeling, Premarket
Published
August 23, 2024
Last updated
August 22, 2024
Description
This document provides guidance on FDA and industry procedures for Section 513(g) requests under the Federal Food, Drug, and Cosmetic Act.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)