The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has launched new resources to help applicants navigate the agency’s premarket tobacco product application (PMTA) process.
Specifically, CTP is offering a new webpage with more in-depth information on how to complete the three required PMTA forms to submit and amend pending applications.
Over the last few years, CTP has received more than 26 million PMTAs and made determinations on 99% of those applications.
Based on this experience and communications with applicants, CTP has developed the new online resources, which includes easy-to-access tips to help applicants submit in the future.
“These new online resources are part of CTP’s ongoing efforts to enhance the center’s efficiency, effectiveness, and transparency in response to recommendations from an independent external evaluation led by the Reagan-Udall Foundation,” a release states.
These latest resources build on tips CTP provided earlier this year for applicants preparing amendments to pending PMTAs.