The agency says it has accepted over 1,600 applications, with the vast majority being for vaping products. Read More
Search Results for: pmta
How effective must a product be in helping adult smokers quit to overcome the theorized level of harm to youth?Read More
The industry group says Triton’s MDO appeal involves issues of ‘exceptional importance.’Read More
AVM says its members have received more acceptance letters than FDA acknowledges for entire industry. Read More
Litigation
News This Week
PMTA
Regulation
U.S. FDA
Vapor Makers Prevail Over FDA in PMTA Denial Suit
The FDA’s refusal to review marketing plans was error and not harmless (disagreeing with Fifth and DC Circuits).Read More
Despite onerous requirements on applicants, the agency was happy to cut its own paperwork, writes Filter.Read More
CTP's King stated that the agency was "making significant progress" in reviewing the applications.Read More
The laboratory provides all non-clinical evidence required to bring a new nicotine product to market.Read More
The limited product debut in the UK has received overwhelming recognition from users and commercial partners.Read More
As FDA has delayed for more than nine months past the Sept. 9, 2021, deadline on finalizing its PMTA reviews.Read More
