Smoking is one of the most efficient and effective methods of delivering a drug to the lungs; which is one of the reasons smoking provides such efficient and quick drug delivery is the way that the...
It's all ENDS in Miami
May 3, 2019 | Published by Joanna Marshall
There was plenty of lively discussion and debate at this week’s Next Generation Nicotine Delivery Conference in Miami – the impact of perceived ENDS safety concerns, the ongoing youth vaping and flavor debate, and FDA enforcement, to name a few topics. Oh, and of course PMTA.
Chris Allen and Andy Mooney from Broughton attended the event taking place over 2 days at Eden Roc Miami Beach. Alongside an impressive line-up of speakers, Chris delivered content and answered questions specifically on the US PMTA regulatory pathway. In particular, he explained how to manage the cost of the PMTA process without compromising on potential success.
The agenda for the event was extensive with attendees including business owners and subject experts from across the sector. A few key highlights we’ve come away with include:
The Youth use issue in the US is undoubtedly still the hottest topic and remains a huge threat to the future of the industry.
On the topic of ENDS product safety, Ian Jones from JTI quoted Professor John Newton from Public Health England – “It would be tragic if false safety concerns limited the opportunity of e-cigarettes to help smokers quit”.
There was consensus that ENDS companies want to see more FDA enforcement action against those ignoring the rules. Although stifling innovation, enforcement against companies marketing products launched after the 8th August 2016, was often referenced.
Whilst some companies are making efforts to engage with the FDA, improved and increased collaboration with the regulators would benefit everyone.
Chris Howard from E-Alternative Solutions commented – “Mitch Zeller has stated that revised PMTA guidance is imminent”.
Broughton offer a team of scientific and regulatory experts to manage the full PMTA process. We generate and compile the data you require, consult with the FDA, and submit your PMTA.
To find out what Chris had to say about managing the cost of the PMTA process without compromising on potential success get in touch.