Bridging Speed and Science: How ARAC Supports Fast-Track Approvals

ARAC – Your partner in bridging regulatory agility with public health responsibility.

A push for rapid approvals doesn’t mean cutting corners, and in fact the recent announcement of CTP’s fast tracking of four major manufacturers means quite the opposite. CTP likely knows that these companies have submitted, as always, substantially robust and complete applications for marketing authorization review. It’s likely that these reviews have been expedited because the regulatory body knows that the “science is there” but whether or not the science adequately supports the APPH standard is to-be-determined.

If you choose to accelerate your pathway to market, ARAC is ready to partner with you for success. We have a proven track record of upholding rigorous scientific standards while delivering Module 6 studies under expedited timelines, and within your regulatory strategy and resources.

SUMMARY:

• Fast-Track Pilot Launched (Sept 9, 2025) – FDA aims to complete reviews by December 2025

• Accelerated reviews on nicotine pouches from four major tobacco companies: PMI, Altria, BAT/RAIS (Reynolds), and Turning Point Brands

• Products Included: Zyn Ultra; on! & on! Plus; Velo mini; Fre & Alp

READ the full article HERE: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-fast-track-nicotine-pouch-reviews-amid-white-house-pressure-2025-09-09/?utm_source=chatgpt.com

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