Court records show the FDA failed at reviewing PMTA data as required, only seeking specific studies. Read More
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In its haste to process millions of PMTAs, the FDA took a shortcut, documents suggest. Read More
The rules reflect clarifying changes made from the previous versions, but no significant substantive changes.Read More
The company has not received a marketing denial orders (MDOs) or refuse-to-file letters.Read More
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