News & Insights
At Accorto Regulatory Solutions we are always keeping a close eye on news in our areas of expertise. Stay up to date with Insights and News from Accorto Regulatory Solutions by signing up for our Newsletter!
News
November 24, 2023
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 [...]
September 16, 2023
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 [...]
September 16, 2023
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. [...]
July 12, 2023
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 [...]
June 22, 2023
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 [...]
June 22, 2023
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 [...]
Insights
January 4, 2022
Mask Manufacturing Matters - Benefits of Buying Domestic It’s no secret that COVID-19 has generated new heights of demand for face masks in [...]
January 4, 2022
The PACT Act and What it Means for the Electronic Cigarette Industry What it is: On December 27, 2020, the President [...]
January 4, 2022
5 Things Your PMTA Needs to Make it to Substantive Review Over the past few months, some of the mystery has lifted surrounding [...]
