The FDA hopes to achieve a common understanding around the basic processes regarding its premarket applications. Officials want to propose new rules to help the industry on topics such as substantial equivalence, premarket tobacco applications, modified-risk tobacco product applications and tobacco product manufacturing practices. The agency will begin publishing these foundational proposed rules in the coming months. The goal will be to lay out a “transparent, modern and science-based framework for manufacturing practices and the development of tobacco product applications that meet the legal requirements,” officials said on its website.
Illutration: Shutterstock