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The purpose of this document is to provide guidance on the types of fees the FDA is authorized to collect under the Animal Generic Drug User Fee Act and how to request a waiver or a reduction of these fees.
The U.S. Food and Drug Administration (“FDA” or “we”) is issuing this Small Entity Compliance guide to help explain the actions that a small entity must take to comply with 21 CFR parts 130 and 131 after recent changes made in 2021 and 2022.
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
OSHA's National Advisory Committee on Occupational Safety and Health is set to meet on December 12 to discuss key issues in workplace safety, including mental health for healthcare workers and whistleblower protection, marking a significant event for occupational health professionals.
This guidance document provides the FDA’s recommendations on a risk-informed framework for credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions.