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  • Regulatory NewsRegulatory News

    FDA issues COVID-19 vaccine EUA guidance after clash with White House

    Amid reports that the White House had blocked stricter guidance from the US Food and Drug Administration (FDA) on emergency use authorizations (EUAs) for COVID-19 vaccines, the agency on Tuesday issued guidance hours after disclosing some of its advice to vaccine makers in briefing documents for an upcoming advisory committee meeting.   Last month, agency officials, including FDA Commissioner Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director...
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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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    Experts call on Hahn to shield FDA from political influence

    More than 30 leading experts and academics in regulatory science and medicine have signed an open letter calling on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to protect the agency from political interference.   The letter comes days after President Donald Trump, who has repeatedly claimed that a coronavirus disease (COVID-19) vaccine could be authorized before the November election and accused FDA staff of being part of “the deep state,” said ...
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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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    Drugmakers, FDA try to build public confidence in COVID vaccine decisions

    The CEOs of nine pharmaceutical companies working to develop vaccines for coronavirus disease (COVID-19) on Tuesday pledged not to seek approval or emergency use authorization (EUA) for a vaccine until they have demonstrated safety and efficacy through Phase 3 clinical trials.   The CEOs, who head vaccine front-runners AstraZeneca, Moderna and partners Pfizer and BioNTech, as well as GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi, also say they will pu...
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    Hahn: COVID-19 vaccine decision will be "deliberative"

    The commissioner of the US Food and Drug Administration assured physicians and other healthcare providers that vaccine and therapeutics approvals for the COVID-19 pandemic will be “based on good science and sound data.”   “Nothing else will be used to guide our decisions,” said Stephen Hahn, MD, speaking at a virtual meeting held by the Reagan-Udall Foundation on 10 August.   Hahn delivered prepared remarks along with American Medical Association president Patric...
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    Drugmakers to Congress: Trust an FDA-approved COVID-19 vaccine

    The public should have confidence in any COVID-19 vaccine approved by the US Food and Drug Administration (FDA), according to the testimony presented by five top pharmaceutical executives at a hearing of the House Energy & Commerce Subcommittee on Oversight and Investigations on 21 July.   The executives – representing AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer – also stressed that the agency does not appear to be lowering its standards to rush a vacci...
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    Euro Regulatory Roundup: EU health committee calls for EMA to get wider remit, more staff to stop shortages

    A key health committee has called for the European Medicines Agency (EMA) to get a wider remit and an increased headcount to prevent shortages of essential medicines. The European Parliament committee made the request in a report that argues EMA should be made the regulatory authority in charge of preventing shortages.   In recent months, multiple Parliament committees have begun considering how to address the emerging problem of medicine shortages. As the group primar...
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    Experts urge transparency, advisory committee review for COVID-19 vaccines

    At a virtual briefing on Tuesday, several experts told members of the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy that a transparent process and advisory committee review will be key to the effective rollout of a vaccine to prevent coronavirus disease (COVID-19).   The briefing comes just two weeks after the US Food and Drug Administration (FDA) issued guidance on the development and licensure of vaccines against SARS-CoV-2, the...
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    Marks on COVID-19 vaccine efficacy, EUAs and challenge trials

    A week after the US Food and Drug Administration (FDA) issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and Research, shed light on the reasoning behind the agency’s 50% efficacy threshold and where the agency stands on challenge trials and emergency use authorizations (EUAs).   Efficacy and approval   In its guidance, FDA said it expected sponsors to demonstrate a vaccine is at leas...
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    ICMRA outlines shape of Phase 3 COVID-19 vaccine trials

    A new report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2, the virus that causes COVID-19. The report indicates which clinical and preclinical data will indicate a vaccine is ready for Phase 3 trials; it also lays out key considerations in designing Phase 3 clinical trials of vaccines for COVID-19.   The report reflects consensus reached at a 22 June 2020 teleconference convened by the US Foo...