Don’t Just Win a PMTA Battle, Win the PMTA War
At Accorto Regulatory Solutions, we work with companies who are pushing back on the FDA’s arbitrary and wholesale issuance of Market Denial Orders (MDOs). Companies that had the resources and commitment to demand that the FDA conduct a legitimate review of each PMTA now run the risk of winning their legal battle but ultimately losing in their efforts to gain market authorization when the final application review is conducted. If you have concerns about the quality or thoroughness of your PMTA(s), there may still be steps you could take to significantly improve the odds of getting full PMTA approval. Those that aren’t just buying time, but who hope to be among the few long-term survivors, are choosing a two-pronged strategy: legal and regulatory.
Our team has submitted PMTAs for over 300 products, and all of these PMTA’s are in the very small minority that remain under review by the FDA. We can help improve your odds of extending the review period by filling gaps in your applications, while coordinating with your legal counsel and communicating with the FDA on your progress to help avoid a premature decision. We understood the expectations of the FDA prior to the initial submission deadline and continue to work hard to keep up with the FDA’s apparent evolving views on topics such as youth uptake and “fatal flaw” philosophies related to flavored products. Now that the FDA has revealed their most recent thinking on flavors, we have developed a range of strategies to address Agency expectations for switching studies and/or “longitudinal cohort studies” that leverage our prior success in combining both hard analytical science with strong “perception and behavior” science.
Through our direct involvement with some of the higher profile legal challenges to the FDA’s absurd MDO actions back in September, we are confident that the vaping industry will be successful in forcing the FDA to conduct legitimate reviews on each PMTA. If you have concerns about your applications as they stand with the FDA, you probably have concluded that time is not on your side. With current legal challenges likely to begin reaching settlement within the next 60 days, this remaining time must be used strategically. Our team at Accorto Regulatory Solutions can quickly conduct a no-cost “gap analysis” on your application and provide a list of recommendations on how your PMTAs could be iteratively improved, within your budget, while coordinating with FDA on your efforts, with the objective of buying time to keep your products on the market longer and improving the odds of ultimate approval.
At Accorto Regulatory Solutions, we work with companies who are pushing back on the FDA’s arbitrary and wholesale issuance of Market Denial Orders (MDOs). Companies that had the resources and commitment to demand that the FDA conduct a legitimate review of each PMTA now run the risk of winning their legal battle but ultimately losing in their efforts to gain market authorization when the final application review is conducted. If you have concerns about the quality or thoroughness of your PMTA(s), there may still be steps you could take to significantly improve the odds of getting full PMTA approval. Those that aren’t just buying time, but who hope to be among the few long-term survivors, are choosing a two-pronged strategy: legal and regulatory.
Our team has submitted PMTAs for over 300 products, and all of these PMTA’s are in the very small minority that remain under review by the FDA. We can help improve your odds of extending the review period by filling gaps in your applications, while coordinating with your legal counsel and communicating with the FDA on your progress to help avoid a premature decision. We understood the expectations of the FDA prior to the initial submission deadline and continue to work hard to keep up with the FDA’s apparent evolving views on topics such as youth uptake and “fatal flaw” philosophies related to flavored products. Now that the FDA has revealed their most recent thinking on flavors, we have developed a range of strategies to address Agency expectations for switching studies and/or “longitudinal cohort studies” that leverage our prior success in combining both hard analytical science with strong “perception and behavior” science.
Through our direct involvement with some of the higher profile legal challenges to the FDA’s absurd MDO actions back in September, we are confident that the vaping industry will be successful in forcing the FDA to conduct legitimate reviews on each PMTA. If you have concerns about your applications as they stand with the FDA, you probably have concluded that time is not on your side. With current legal challenges likely to begin reaching settlement within the next 60 days, this remaining time must be used strategically. Our team at Accorto Regulatory Solutions can quickly conduct a no-cost “gap analysis” on your application and provide a list of recommendations on how your PMTAs could be iteratively improved, within your budget, while coordinating with FDA on your efforts, with the objective of buying time to keep your products on the market longer and improving the odds of ultimate approval.
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