Draft Guidance for Industry and Food and Drug Administration Staff; Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products Under the Federal Food, Drug, and Cosmetic Act; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act." This guidance is intended for manufacturers, retailers, importers, and FDA staff. The guidance describes FDA's current thinking regarding the appropriate preliminary timetable for its review of applications for Modified Risk Tobacco Products (MRTPs) under the Federal Food, Drug, and Cosmetic Act (the act), as modified by the Federal Smoking Prevention and Tobacco Control Act (Tobacco Control Act).