IA, salud y atención médica hoy y mañana
Hace 13 horas
miércoles, 24 de diciembre de 2025
February 10, 2026: Roundtable on Premarket Tobacco Product Application (PMTA) Submissions for Electronic Nicotine Delivery Systems (ENDS) Products February 10, 2026
https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-product-application-pmta-submissions-electronic?utm_campaign=ctp-pmta&utm_content=event&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms
FDA Announces Roundtable Discussion with Small ENDS Manufacturers on Premarket Application Submissions
FDA has issued a Federal Register notice (FRN) announcing a roundtable discussion with small tobacco product manufacturers (fewer than 350 employees) on February 10, 2026, 9 am–5 pm ET. The discussion aims to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products.
Viewing the meeting is open to the public, however roundtable participants are limited to 30 individuals representing manufacturers who have previously submitted an ENDS PMTA, including those with a PMTA currently pending with FDA.
FDA is hosting this roundtable to provide small ENDS manufacturers an opportunity to share their experience with, and other opinions about, the premarket application process. The topics to be discussed will include certain components of ENDS PMTAs such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).
To register for the roundtable as a panelist, please do so at the event page by January 27, 2026, 11:59 p.m. Eastern Time. Registration for panelists is on a rolling basis and is determined by space availability, with priority given to early registrants. FDA will evaluate registrations based on the submitted information until a maximum of 30 participants have been selected for the roundtable. Due to time and space constraints, there is a limit of one person to represent and speak on behalf of each company. Participants should be at a sufficiently senior level with significant scientific and/or regulatory responsibility to be knowledgeable about their company’s PMTA. Panel registrants will receive confirmation as to whether they have been selected. If panelist registration closes prior to the submission deadline, we will update the website to reflect that change.
For non-panelists and members of the public interested in viewing the roundtable virtually, information will be provided on CTP’s website. The meeting will be captioned and recorded. Please visit the event page to learn more about attending the roundtable.
Suscribirse a:
Comentarios (Atom)
.png)
