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  • Regulatory NewsRegulatory News

    FDA’s Office of Compliance details enforcement actions in 2021

    The US Food and Drug Administration (FDA) Office of Compliance (OCC) issued numerous enforcement discretion decisions to increase supplies of critically needed medicines for treating COVID-19 and increasingly relied on the use of inspection alternatives, such as product sampling and reviewing firms’ written response to records, instead of traditional onsite inspections in 2021.   These are some of the areas highlighted in OCC’s latest annual report released 2 May, de...
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    FDA authorizes second round of mRNA boosters for older and immunocompromised people

    The US Food and Drug Administration (FDA) on Tuesday signed off on a second round of COVID-19 vaccine booster shots for immunocompromised individuals and people 50 years of age and older.   The agency said the boosters can be administered four months after receiving the first booster dose of any authorized or approved COVID-19 vaccine in both populations.   The populations covered by the latest authorizations differ from those sought by the two vaccine makers. Pfiz...
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    Stakeholders ask for more time to transition EUA devices, diagnostics

    Responding to two US Food and Drug Administration (FDA) draft guidances on transitioning products granted emergency use authorization (EUA) during the pandemic to regular marketing authorizations, key stakeholders raised concerns the agency isn’t providing enough time to collect the necessary data or make labeling changes after the current public health emergency (PHE) is over.   In December, FDA published two much-anticipated draft guidances titled, “ Transition Plan ...
  • Feature ArticlesFeature Articles

    Cuba’s biotechnology industry and its response to the COVID-19 pandemic

    Abstract T his article examines the origins of Cuba’s biotechnology industry and its roles in supporting the Cuban national healthcare strategy and providing a framework for the country’s response to the global COVID-19 pandemic. The author also provides a brief overview of the Cuban regulatory landscape . Keywords – biotechnology, CECMED, COVID-19, Cuba, vaccine.   Background and introduction The Cuban pharmaceutical and biotechnology industry emerged in the...
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    FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies

    The US Food and Drug Administration (FDA) is proposing to give medical device makers 180-days’ notice before terminating emergency use authorizations (EUAs) and phasing out its enforcement policies for medical devices issued during the COVID-19 public health emergency (PHE).   The transition plan comes in the form of two draft guidances issued in late December, in which FDA explains that the transition policies are intended to “prepare manufacturers and other stakehold...
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    European Commission identifies 10 ‘promising’ COVID treatments

    The European Commission (EC) on 22 October released a list of the 10 “most promising treatments” for COVID-19 as part of its strategy to support the development of new therapies.   A panel of scientific experts selected the 10 drugs from a pool of 82 therapeutic candidates that are in late-stage clinical development.    “In selecting the 10 most promising candidates, experts focused on the product categories with the highest potential impact on the pandemic: produc...
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    ICMRA: Industry's commitment to quality can facilitate regulatory flexibility

    Frequent communication with industry and relying on assessments by other regulators have enabled the rapid scale-up of COVID-19 vaccines and therapeutics, asserted regulators and industry representatives attending a July workshop sponsored by the International Coalition of Medicines Regulatory Authorities (ICMRA).   The workshop explored how different regulatory tools are being deployed to increase manufacturing capacity for vaccines during the COVID-19 pandemic. The...
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    FDA to convene VRBPAC on vaccines for younger children plus Moderna, J&J boosters

    Amid the nationwide rollout of booster shots of the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration (FDA) on Friday announced it will convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss potential booster doses for the other two US-authorized COVID-19 vaccines developed by Moderna and Johnson & Johnson (J&J) later this month.   The committee will also meet on 26 October to discuss Pfizer's anticipated request...
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    Kaleido warned; FDA not persuaded by 'medical food' claim

    The US Food and Drug Administration (FDA) recently issued a warning letter to Kaleido Biosciences for administering an investigational new COVID-19 treatment to patients without obtaining an investigational new drug (IND) application.   The company argued that the product under investigation was a food and not a drug, and therefore not subject to IND filing requirements. Yet the agency disagreed, saying that the endpoints used in the clinical trials went beyond ‘diet...
  • Feature ArticlesFeature Articles

    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
  • Feature ArticlesFeature Articles

    ‘Immune’ claims and COVID-19

    Correction and Editor’s note: The article, ‘Immune’ claims and COVID-19 (published 30 June 2021) incorrectly stated that Vi-Jon Inc. had received a warning letter from the FDA, when in fact it had not received such a letter. The article was corrected on 15 July 2021, but the correction was not appropriately noted on our website. The article was further updated on 27 August 2021 to remove an extraneous reference. Regulatory Focus regrets these errors and apologizes. ...
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    FDA: No plans yet to resume onsite GMP foreign inspections

    An official with the US Food and Drug Administration (FDA) said the agency has no plans to resume onsite foreign inspections for operations that are not deemed “mission critical” during the COVID-19 public health emergency. Instead, the agency is relying on the expanded use of mutual recognition agreements as an alternative tool for boots-on-the-ground inspections.   So asserted Alonza Cruse, the director of pharmaceutical quality operations in FDA’s Office of Regulato...