FDA Plays

[duderino]

"Based on all these considerations, FDA has determined that, as a reasonable preliminary timetable, the Agency intends to issue a decision on a MRTP application within 360 days of its receipt by FDA."

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM191915.pdf


The company also submitted two applications for approval of dissolvable smokeless tobacco products in 2010: Ariva-BDL™ in February, and Stonewall-BDL™ in June.

http://www.prnewswire.com/news-releases/star-scientific-files-stonewall-moist-bdl-application-with-fda-for-approval-as-modified-risk-tobacco-product-115099009.html