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    HHS, FDA dispute spills out onto Twitter

    In the final months and weeks of the Trump administration, the Department of Health and Human Services (HHS) has advanced several policies to consolidate its authority over the US Food and Drug Administration’s (FDA). Today, with just one day left in the Trump administration, the latest dispute between HHS and its subagency spilled into the public. Following media reports last week that FDA Commissioner Stephen Hahn refused to sign a memorandum of understanding (Mo...
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    Hahn offers advice to incoming Biden administration

    With the transition to a new administration less than two weeks away, US Food and Drug Administration (FDA) Commissioner Stephen Hahn on Friday told reporters at an Alliance for Health Policy briefing that he has offered his help to the incoming administration but does not expect to stay on as commissioner.   “I have had the opportunity to talk to transition team and I have certainly offered my willingness to help after the transition in any way that they see fit,” Hah...
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    Hahn addresses EUAs, transition to approvals in conversation with RAPS members

    Real-world data has proven useful in demonstrating the performance of COVID-19 diagnostics, but has not always lined up with the data submitted to support the emergency use authorizations (EUA) of those product. That was one message Stephen Hahn, MD, US Food and Drug Administration (FDA) commissioner brought to RAPS members during a conference call on Tuesday.   “The real-world application of these tests differs from the science and data that are used for us to make th...
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    Hahn insists FDA will stick to guidelines for COVID-19 vaccine decisions

    Speaking at the Financial Times ’ US Pharma and Biotech Summit on Tuesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said the agency will stick to the standards and criteria it has laid out to approve or authorize applications for vaccines to prevent coronavirus disease (COVID-19).   In recent weeks, Hahn has made numerous statements asserting that the agency will not approve or authorize a vaccine that does not meet the agency’s “rigorous expect...
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    Hahn pledges no politics in COVID vaccine decisions

    Testifying before the Senate Health, Education, Labor and Pensions Committee on Wednesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said that politics will not play a part in the decision to approve or authorize a vaccine for coronavirus disease (COVID-19).   Hahn stressed that he supports science and has “100% confidence” in his staff, and said that, “FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous ...
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    Marks, Hahn confirm COVID vaccine EUA guidance coming

    The US Food and Drug Administration (FDA) will soon issue guidance on the data needed to support an emergency use authorization (EUA) for a vaccine to prevent coronavirus disease (COVID-19) according to Center for Biologics Evaluation and Research (CBER) Director Peter Marks.   Speaking at an event hosted by the Duke Margolis Center for Health Policy on Thursday, Marks hinted that additional guidance on EUAs for COVID-19 vaccines would be coming soon.   “You may ...
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    Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals

    US Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, on Tuesday testified before the House Energy and Commerce Committee on his agency’s response to the coronavirus disease (COVID-19) pandemic.   User fee goals, policy review   Despite an “incredible surge in volume” of applications and constraints on the agency’s ability to conduct inspections, Hahn said that FDA, “Has maintained the same pace of meeting its goals on applications for medical produc...
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    Trump Nominates Hahn to be FDA Commissioner

    President Donald Trump on Friday nominated Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next US Food and Drug Administration (FDA) commissioner. If confirmed by the Senate, a process that could take several months, Hahn will take the reins of FDA from Acting Commissioner Ned Sharpless, who moved over to FDA following a stint as head of the National Cancer Institute (NCI). Sharpless will return to direct NCI, while Brett Gi...
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    Acting FDA Commissioner Stephen Ostroff to Speak at RAPS' Regulatory Convergence

    Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff , MD, will speak to attendees of the 2015 RAPS Regulatory Convergence . RAPS’ signature annual event for the regulatory profession will take place 24–28 October in Baltimore. Ostroff will speak 27 October, delivering a special keynote address, then he will participate in a panel discussion on key agency activities and initiatives. Other expert panelists are expected to be announced in...
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    FDA Commissioner Margaret Hamburg to Resign Next Month

    Margaret Hamburg, one of the longest-serving commissioners in US Food and Drug Administration (FDA) history, plans to announce her resignation tomorrow, FDA officials have confirmed to Regulatory Focus . Hamburg's final day at the agency will be in late March 2015, Hamburg wrote in an email. She will be succeeded on an acting basis by Stephen Ostroff , FDA's chief scientist since January 2014 . A Long Tenure Hamburg's resignation brings to an end one of the longest ...