News & Insights
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News
FDA Conducts Retailer Inspection Blitz, Cracks Down on Illegal Sales of Popular Disposable E-cigarettes
Today, the U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were [...]
FDA and NIH Award Funding for New Center for Rapid Surveillance of Tobacco
FDA and the National Institutes of Health (NIH) have awarded funding for a new Center for Rapid Surveillance of Tobacco (CRST). Through rapid surveillance and reporting of information, CRST will enhance CTP and the research [...]
FDA Announces Additional Steps to Modernize Clinical Trials
Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile [...]
Insights
FDA Releases Long Awaited PMTA Submissions List
FDA Releases Long-Awaited PMTA Submissions List May 20th, 2021 Today, May 20th, 2021, FDA released the “Deemed New Tobacco Product Applications Lists” the electronic nicotine delivery systems (ENDS) industry has [...]
What FDA’s Recent PMTA Denials Mean for the E-Cigarette Industry
What FDA's Recent PMTA Denials Mean for the E-Cigarette Industry Background With the FDA’s deadline of September 9, 2021 to finalize the review of all PMTA’s that had [...]
Differences in US FDA Medical Device Classifications
Differences In US FDA Medical Device Classifications In the United States, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who [...]
