Altria Seeks PMTA Extension From U.S. FDA
- Covid-19 News This Week Regulation U.S. FDA
- March 30, 2020
- 2 minutes read
Altria has sent a letter to the U.S. Food and Drug Administration (FDA) requesting that the agency push back the May 12 authorization deadline by eight weeks due to the coronavirus outbreak.
In order to keep certain tobacco and nicotine products on the market, companies must submit applications to the FDA by May 12, but many companies have been disrupted due to the virus outbreak; many companies have asked employees to work from home, factories have temporarily closed and Altria’s CEO contracted the virus.
Altria has requested that the FDA seek an extension following the eight-week social distancing recommendation from the U.S. Centers for Disease Control and Prevention.
“Although we make this request and raise these issues given these unprecedented times, we remain committed to working with the agency on these important product submissions,” Paige Magness, Altria’s senior vice president, said in a letter. The company has asked that if an extension is not possible the FDA allow companies to submit data and product samples after the deadline if they are affected by the outbreak.