The Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has recently released a new webpage aimed at assisting applicants in gaining a better understanding of the agency’s pre-market tobacco product application (PMTA) process. This webpage provides more comprehensive information, including guidance on how to complete, submit, and amend the three PMTA forms required for pending applications.
In the past few years, CTP has received over 26 million PMTA applications and has made decisions on 99% of these applications. Building on this experience and communication with applicants, CTP has developed new online resources, including easily accessible tips, to assist future applicants.
A press release states, “These new online resources are part of CTP’s ongoing efforts to enhance the efficiency, effectiveness, and transparency of the center in response to recommendations from an independent external evaluation led by the Reagan-Udall Foundation.”
