Where ‘The Buck’ Will Stop On FDA’s Vaccine Review
Peter Marks, a top Food and Drug Administration career official, is likely to decide in the next several months whether a coronavirus vaccine is safe and effective enough to be given to tens of millions of Americans.
The Washington Post:
Meet The Most Important Federal Official You Probably Don’t Know — The Man Who Holds The Fate Of The Coronavirus Vaccine In His Hands
Peter Marks, a self-effacing cancer doctor known for his maniacal work ethic and straight-arrow approach, is sitting on the hottest of hot seats. A top Food and Drug Administration career official, Marks is likely to decide in the next several months whether a coronavirus vaccine is safe and effective enough to be given to tens of millions of Americans. That may be among the most critical decisions in the history of the agency, one with sweeping health, economic and political consequences. (McGinley, 8/11)
In other FDA news —
CNN:
Lawmakers Urge The FDA To Temporarily Clear E-Cigarettes From Market
In a letter to the US Food and Drug Administration, lawmakers are urging the agency to temporarily clear the market of all e-cigarettes for the duration of the coronavirus crisis. (Howard, 8/11)
CBS News:
Gilead Seeks FDA Approval For COVID-19 Drug Remdesivir
Gilead Sciences on Monday applied for approval from the U.S. Food and Drug Administration for its COVID-19 treatment, remdesivir. The biotech company also said the antiviral drug will go by the brand name of Veklury in the U.S. (Gandel, 8/11)