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  • Regulatory NewsRegulatory News

    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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    2015 Regulatory Convergence Highlights: Stephen Ostroff's Keynote

    One of the big draws of attending RAPS’ annual Regulatory Convergence is the opportunity to hear directly from regulators. Each year, the Convergence features dozens of speakers and panelists representing global regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the China Food and Drug Administration and many others. Among the highlights of last year’s Convergence in Baltimore was the opportu...
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    Congressional Hearings Focus on Compassionate Use, FDA Issues

    Aside from Thursday’s summit on President Barack Obama’s Precision Medicine Initiative (which can be viewed in its entirety  here ), the Senate and House held two other hearings focused on the inner workings of the US Food and Drug Administration (FDA). At the Senate Homeland Security and Government Affairs Committee hearing, senators discussed FDA’s compassionate use program with the Goldwater Institute’s Dary Olsen, who’s been behind all of the Right-to-Try state legi...
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    FDA Commissioner Outlines Critical Time Ahead for Agency

    As the US Food and Drug Administration (FDA) transitions between commissioners, continues negotiating industry user fee commitments and prepares for a possible legislative overhaul, a major transformation is in the works for the agency over the next couple of years. FDA Acting Commissioner Stephen Ostroff told attendees on Tuesday at RAPS' Regulatory Convergence that he's seeing an "unusual confluence" of events, particularly as the House-passed  21st Century Cures leg...
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    Are the Days of FDA Approving 'Basically Everything' Falling by the Wayside?

    In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week. FDA's drug review process has long been recognized as the gold standard globally (FDA even mentioned that gold standard moniker in congressional testimony ) and as recently as 2008, ...
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    Clinton Urges FDA, FTC to Take Action Against Drug Price Hikes

    In two letters sent Monday, Democratic presidential hopeful Hillary Clinton called on the US Federal Trade Commission (FTC) and US Food and Drug Administration (FDA) to take action against pharmaceutical companies that inflate drug prices and keep generics off the market. In her letter to FDA acting commissioner Stephen Ostroff, Clinton echoes a number of similar calls by politicians such as those by Rep. Elijah Cummings (D-MD) , that Turing Pharmaceuticals' 5,000% pric...
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    Acting FDA Commissioner Stephen Ostroff, Author Daniel Pink to Headline RAPS' Regulatory Convergence Conference in Baltimore

    RAPS’ annual Regulatory Convergence is now less than three weeks away. The event, taking place this year 24–28 October in Baltimore, is the largest annual gathering of the global healthcare regulatory community, including healthcare product regulators, scientists, innovators, and regulatory professionals from life sciences companies of all sizes. This year’s conference will feature keynote remarks from Acting Commissioner of the US Food and Drug Administration (FD...
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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 ...