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Altria sent a letter to FDA requesting an eight week delay in PMTA submission

2020/04/01|本站原创|Industry news

Altria

According to reports, novel coronavirus pneumonia, the Asia Group has written to the US Food and Drug Administration (FDA), request the agency to postpone the May 12th PMTA deadline eight weeks.

Altria said novel coronavirus pneumonia products should be submitted to FDA before May 12th, but many companies have broken down due to the outbreak of new crown pneumonia. The novel coronavirus pneumonia is also being infected by many companies requiring their employees to work at home and factories temporarily closed.

It is understood that novel coronavirus pneumonia chairman and CEO Howard A Howard III (Howard A. Willard III) has been taking sick leave after being infected with the new crown pneumonia. William F. Gifford, chief financial officer, will temporarily take on Willard's responsibilities.

Altria asked the FDA to seek an extension based on eight weeks of social estrangement advice from the Centers for Disease Control and Prevention (CDC).

Paige Magness, senior vice president of Altria, said in a letter: "although we made this request and raised these issues in an unprecedented era, we are still committed to working with the agency to deal with these important products."

Altria also requested that if the extension is not possible, the FDA allow the company to submit data and product samples after the deadline in the event of an outbreak.

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