News & Insights

RICHMOND, VIRGINIA - NOV. 24, 2023 At Accorto, we strive to continuously look for ways to expand our capabilities to better serve our clients. Today we are excited [...]

FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and De Novo [...]

Today, the U.S. Food and Drug Administration issued three new draft guidances to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices. [...]

On December 29, 2022, the Modernization of Cosmetics Regulation Act (MoCRA) was passed into law in the United States. The first major update to the Food and [...]

Today, the U.S. Food and Drug Administration is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. These proposed requirements [...]

Today, FDA issued marketing denial orders to the firm Mothers Milk WTA for more than 250 flavored and tobacco-flavored e-liquids. After completing initial acceptance review and subsequently proceeding [...]

The FDA Deficiency Letter Response Process for Premarket Tobacco Applications: How to Survive Substantive Scientific Review The Substantive Review Process: Once [...]

Your Vape PMTA & FDA's New Consumer Research Guidance On Oct 27, FDA’s Office of Science and Office of Regulation in the Center [...]

Understanding Vape PMTA Statuses If you’re following PMTA submissions, you’ve probably seen many press releases from vape companies detailing the status of their [...]