The agency issued 29 warning letters in the month of August, with the total number of letters now at 169.Read More
The regulatory agency did not release the names of the companies that received marketing denial orders.Read More
All marketing denial orders (MDOs) from the FDA have been for flavored products other than tobacco.Read More
The U.S. Food and Drug Administration issued the first marketing denial orders for ENDS products today.Read More
As the FDA’s deadline to approve PMTAs nears, industry experts look back on the submission process.Read More
The PMTA process has had some errors and challenges as the FDA’s decision deadline looms.Read More
Scientific review is the final step in the PMTA process prior to FDA's decision to grant a marketing order.Read More
Broughton's Paul Hardman explores common causes and offers suggestions on how to prepare for them.Read More
The letter notified the company that the majority of their PMTAs did not meet the filing requirements.Read More
The FDA states that the company, Visible Vapors, did not submit PMTAs by the Sept. 9, 2020 deadline.Read More