FDA applications meeting

The US Food and Drug Administration’s Center for Tobacco Products (CTP) is due to explain the processes it uses in the review of tobacco product applications. Vapor products are considered a tobacco product by the CTP.

In a press note, the FDA said it planned to hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on April 6.

‘During this meeting, representatives from the FDA’s Center for Tobacco Products will present information to the Committee, which includes several new members, on the processes CTP uses in the review of tobacco product applications, including substantial equivalence (SE), modified risk tobacco product (MRTP) and premarket tobacco applications (PMTA),’ the note said. Vapor companies are expected to have to survive at least one of the regulatory pathways to keep products on the market.

‘Topics will include the statutory standards applicable to the different types of applications; the scientific basis for review decisions, with a focus on PMTA and MRTPA; and the role of the committee in the review process.

‘People interested in presenting data, information, or views, either in person or in writing, must send in their submissions by March 15 or March 23, respectively.’