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  • FDA launches digital health center of excellence

    A new digital health Center of Excellence within the US Food and Drug Administration (FDA) aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.   The DHCoE’s website details services offered, including examples of CDRH-specific, FDA-wide and external efforts to “translate digital advances into tools that benefit consumers.” The Center is housed within FDA’s Center for Devices and Radiological Health (...
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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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    FDA updates benzodiazepine boxed warning

        The US. Food and Drug Administration (FDA) is requiring that the boxed warning on benzodiazepines be updated to provide a uniform description of the risks associated with all medications in the class.   On 23 September 2020, FDA announced in a Drug Safety Communication that current prescribing information for benzodiazepines "does not provide adequate warnings about the serious risks and harms associated with these medicines, so they may be prescribed and used ...
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    GAO highlights continued PPE shortages in COVID-19 report

    The United States continues to struggle with shortages of personal protective equipment (PPE) and testing supplies due to high global demand and the fact that most supplies are made outside of the US, according to new findings from the US Government Accountability Office (GAO).   In a wide-ranging report on the US federal response to COVID-19, the GAO issued 16 new recommendations for federal agencies spanning the medical supply chain, vaccines and therapeutics, COVI...
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    FDA issues proposed rule clarifying stance on intended use

    After delaying implementation of parts of its final rule on intended uses multiple times, the US Food and Drug Administration (FDA) on Tuesday proposed a new rule clarifying its position on the types of evidence it will consider when determining a product’s intended use. The new rule would also repeal and replace the unimplemented portions of the earlier final rule.   The saga to update FDA’s intended use regulations began in 2015, when the agency first issued a propos...
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    Recon: UK to host COVID vaccine challenge trials; Roche, AC Immune Alzheimer’s drug flops in Phase 2 study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA poised to announce tougher standards for a covid-19 vaccine that make it unlikely one will be cleared by Election Day ( Washington Post ) ( FT ) ( NYTimes ) ( Reuters ) CDC Advisory Panel to Delay Vote on Initial Covid-19 Vaccine Rollout ( WSJ ) US health agency sets October 16 deadline for states to submit vaccine plans ( Reuters ) J&J kicks off final stu...
  • Feature ArticlesFeature Articles

    Gene therapies – The regulatory road to individualized medicine

    This article discusses the evolving US regulatory landscape for gene therapies. The author explores the recent history and developmental paradigm shifts for gene therapy products and concludes with advice for abbreviated development and thoughts on policies that will create a sustainable gene therapy ecosystem. The author examines the paradigm shift of clinical trial and lifecycle management for gene therapies and considers the changes to the US regulatory framework that ...
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    Generic drugmakers get cannabidiol bioequivalence guidance from FDA

    Manufacturers who seek to produce generic versions of cannabidiol oral solution received guidance from the US Food and Drug Administration (FDA) on establishing bioequivalence with the reference listed drug.   The guidance follows the June 2018 approval of Epidiolex (cannabidiol) oral solution to treat seizures associated with two rare and serious types of childhood epilepsy. Epidiolex was also approved to treat a third seizure condition, tuberous sclerosis complex, in...
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    RAPS welcomes new Ontario Chapter

    RAPS has announced the official launch of the RAPS Ontario Chapter , which first began as a RAPS-affiliated local networking group. Ontario joins Vancouver as the second RAPS chapter in Canada and expands RAPS’ global network to now include 20 chapters and eight local networking groups. “We are very excited about the formal launch of our chapter in the RAPS regulatory community,” said founding member and Ontario chapter chair, Ntsakisi Onibayo, RAC, regulatory complian...
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    COVID-19 vaccine: Experts warn of waning public confidence

    Conflicting messages and priorities between vaccine makers and federal leaders serve only to exacerbate public mistrust of potential COVID-19 vaccines, according to a perspective piece from Harvard professors published in the New England Journal of Medicine .   Jerry Avorn, MD, and Aaron Kesselheim, MD, both from the division of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School, took to the august publication to share their thoughts on the juxtaposi...
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    Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance

    Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel coronavirus pandemic, according to an updated guidance from the US Food and Drug Administration (FDA).    The updated information came on 21 September 2020 in the form of a new addition to the questions and answers in the FDA's guidance on conduct of clinical trials of medical pro...