Navigating FDA’s Complex Regulation of Homeopathic and Ayurvedic Products
The U.S. Food and Drug Administration (FDA) has announced its new medical device user fees for fiscal year 2025, effective October 1, 2024, highlighting significant
Enhancing Safety and Efficiency
FDA Proposes Modifications to Medical Device User Fee Small Business Qualification and Certification
FDA Makes Changes to Device GMPs to Align More Closely with International Consensus Standards.
FDA’s 2023 device registration renewal period!
FDA’s Regulation of OTC Hearing Aids vs. PSAPs Last fall, FDA released its final rule establishing a regulatory category for Over-the-Counter (OTC) hearing aids, pursuant