Head of FDA Stephen Hahn, Commissioner Oct. 2020
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Posted On: 01/11/2021 1:32:13 AM
Head of FDA Stephen Hahn, Commissioner
Oct. 2020
“Now, you and I, I think we both would agree as doctors, if there are data available on any therapeutic that look like it could save a life during a pandemic, and it is safe and it fulfills the criteria of "may be effective," and the risk-benefit ratio is in the right direction, then we should go forward with it."
"But we intend to be transparent about the rationale behind an EUA, when and if it occurs, for therapeutics. We're going to have to encourage the sponsors to be transparent about the information we provide them, because we are restricted by law from releasing confidential commercial information. But we will, to the extent allowed, be very transparent about it.”
Oct. 2020
“Now, you and I, I think we both would agree as doctors, if there are data available on any therapeutic that look like it could save a life during a pandemic, and it is safe and it fulfills the criteria of "may be effective," and the risk-benefit ratio is in the right direction, then we should go forward with it."
"But we intend to be transparent about the rationale behind an EUA, when and if it occurs, for therapeutics. We're going to have to encourage the sponsors to be transparent about the information we provide them, because we are restricted by law from releasing confidential commercial information. But we will, to the extent allowed, be very transparent about it.”
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