The largest community of pharma leaders

AIR FACTORY® (PMTA) Premarket Tobacco Application Moves Into FDA Substantive Scientific Review

IRVINE, Calif.–()–My Vape Order, Inc. (MVO), a trusted provider of nicotine e-liquid products marketed under the AIR FACTORY® brand, has announced that on October 9, 2020, the U.S. Food and Drug Administration (FDA) issued a Filing Letter notifying MVO that the AIR FACTORY® Premarket Tobacco Application (PMTA) met FDA’s PMTA filing requirements and was moving forward into FDA’s substantive scientific review phase.

MVO’s CEO, Kyle Godfrey, commented, “[i]n this critical phase, FDA will review the extensive scientific data and research submitted with the AIR FACTORY® PMTA to determine whether the AIR FACTORY® products consumers know and love are ‘appropriate for the protection of public health’ – the standard that FDA considers when deciding which products to allow for sale. The AIR FACTORY® PMTA was the culmination of years of planning and extensive toxicological testing and scientific research. We look forward to working with FDA on its review of the AIR FACTORY® products, with the ultimate goal of obtaining FDA marketing orders for the products.” Godfrey noted that the company would continue to provide updates regarding FDA’s PMTA review of the AIR FACTORY® products.

Source

Recent Articles

ONK Therapeutics Closes New Financing and Appoints Chris Nowers as CEO

GALWAY, Ireland--(BUSINESS WIRE)--ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has raised US$8M in a financing from...

Transgene: Acceptance of Late Breaking Abstract at Upcoming SITC 2020 Conference, on The Detailed Results From Clinical Study of TG4001 in Combination With Avelumab...

STRASBOURG, France--(BUSINESS WIRE)--Regulatory News: Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, announced that detailed results of...

Akron Biotech Signs Agreement With Synairgen plc to Supply Interferon-beta for COVID-19 Treatment

BOCA RATON, Fla.--(BUSINESS WIRE)--Akron Biotechnology today announced it has signed an agreement with Synairgen plc (LSE: SNG) for the provision of SNG001, Synairgen’s wholly-owned...

Ultimovacs Announces Updated Positive Results from Phase I Trial Evaluating Universal Cancer Vaccine, UV1, in Non-Small Cell Lung Cancer

OSLO, Norway--(BUSINESS WIRE)--Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), today announced five-year overall survival data from the Phase I trial evaluating UV1 as maintenance therapy in...

Genesis Therapeutics Enters AI-driven, Multi-Target Drug Discovery Partnership with Genentech

BURLINGAME, Calif.--(BUSINESS WIRE)--Genesis Therapeutics, a privately-held company inventing and deploying state-of-the-art artificial intelligence (AI) techniques to augment drug discovery and development, today announced that...