The company has not received a marketing denial orders (MDOs) or refuse-to-file letters.Read More
Search Results for: pmta
The regulatory agency released a revised listing of MDOs that now includes 125 company names.Read More
The Wall Street Journal reports the FDA has asked for a PMTA deadline extension for some products.Read More
The UK-based company sells to 86 countries around the world, according to a press release.Read More
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 agency’s recent decision covers only a fraction of products under review, say industry critics. Read More
As the FDA’s deadline to approve PMTAs nears, industry experts look back on the submission process.Read More
Broughton's Paul Hardman explores common causes and offers suggestions on how to prepare for them.Read More
