Broughton Chief Regulatory Officer, Dr Nveed Chaudhary shares his thoughts on the latest FDA announcement, ‘Clarification on General Enforcement Discretion Related to Sept. 9 Premarket Tobacco...
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Broughton Regulatory Operations Manager, Emily Saunders, discusses FDAs announcement on the final ruling for PMTA applications.
Emily discusses the proposed Food and Drug Administration (FDA) recommendations and requirements in this final ruling for Premarket Tobacco Product Applications (PMTA) summarized in a downloadable report.
The Final Rule
FDA released their proposed rule and guidance for the completion for ENDS PMTA applications in 2019. Since then, FDA has received thousands of applications, some of which have been moved into substantive review. On the 19th of January 2021, FDA released their final rule which makes amendments and recommendations to the previous rule and helps ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The purpose of the rule is to improve the efficiency of the submission and review of PMTAs as well as providing applicants with a better understanding of the information a PMTA must contain.
Requirements and Recommendations
PMTA’s are thorough documents and in this final rule, FDA set out both requirements and recommendations for applicants to ensure they understand what to cover in their submissions to achieve acceptance. Amongst other topics, the rule addresses:
- The submitting of detailed information regarding the physical aspects of the new tobacco product and full reports of information regarding investigations that may show the health risks of the new tobacco product.
- Whether the product presents the same or different risks compared to other tobacco products. FDA requires the submission of these health risk investigations to ensure it understands the full scope of what is known about the potential health risks of a new tobacco product.
- Electronic submission of the PMTA.
- Post-market reporting requirements for applicants that receive marketing granted orders.
- Retention of records requirements for PMTAs.
- Procedures by which FDA reviews a PMTA.
Download our more detailed review of the final rule which also includes a link to the formal FDA document.
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