• Regulatory NewsRegulatory News

    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. ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    WHO revises guidance on GMPs for investigational products, R&D facilities

    The World Health Organization (WHO) recently issued a revised draft guidance to industry addressing good manufacturing practices (GMPs) for investigational drug products as well a new draft guideline addressing GMP principles for research and development facilities in the context of the COVID-19 pandemic.   The draft guidance on GMPs for investigational products was prompted by WHO’s Prequalification Team Inspections Services (PQT), which last year expressed the need...
  • Regulatory NewsRegulatory News

    EMA updates COVID-19 vaccine risk management plans to reflect variant safety

    The European Medicines Agency (EMA) wants companies to provide safety information on additional strains or variants in an update to its guidance on risk management plans (RMPs) for COVID-19 vaccines. In the update, EMA also discourages sponsors from using passive surveillance to evaluate vaccine safety due to a lack of robustness in these methods.   The plan should be read in conjunction with EMA guidance on good pharmacovigilance practices, including GVP Module V, Mod...
  • Regulatory NewsRegulatory News

    Warning letter: FDA blasts Innova for falsifying data, GMP violations

    Editor's note: This article has been updated to include a statement from Innova. The US Food and Drug Administration issued a warning letter on 10 June to Innova Medical Group for distributing unauthorized SARS-CoV-2 rapid antigen tests and "false or misleading" information in the tests’ labeling.   The warning letter comes after FDA inspected two of the firm’s facilities in Pasadena and Brea, CA over the course of several weeks in March and April.   FDA also ...
  • Feature ArticlesFeature Articles

    COVID-19 diagnostics: Moving from laboratory to home-based testing

    The US Food and Drug Administration (FDA) has worked closely with diagnostics developers during the past year to facilitate access to COVID-19 testing and accelerate development of home-based tests. By creating a flexible regulatory framework, the agency has enabled authorization of nearly one COVID-19 diagnostic per day, including at-home tests that have a critical role in the ongoing response to SARS-CoV-2. Introduction The emergence of the COVID-19 pandemic create...
  • Regulatory NewsRegulatory News

    FDA may decline new COVID vaccine EUA requests

    The US Food and Drug Administration’s (FDA’s) updated emergency use authorization (EUA) for COVID-19 vaccines says the agency may decline EUA requests from developers that have not yet met with the agency to discuss their vaccines.   This announcement was made by the agency in a 25 May tweet from the account of FDA’s Center for Biologics Evaluation and Research (CBER). The revised guidance supersedes versions issued on 22 February 2021 and October 2020. All versions ...
  • Regulatory NewsRegulatory News

    Legislators blast Emergent officials at House hearing

    Members of the US House of Representatives lambasted officials of Emergent BioSolutions for ignoring serious potential contamination and cleanliness problems at their facility, causing millions of COVID-19 vaccine doses to be thrown out.   The House Select Subcommittee on the Coronavirus Crisis, chaired by Rep. James Clyburn (D-SC) along with the House Committee on Oversight and Reform heard testimony from Robert Kramer, president and chief executive officer of Emerge...
  • Regulatory NewsRegulatory News

    EC advances amendment to speed adapted COVID vaccines

    The European Commission on Wednesday advanced a delegated regulation that would give the European Medicines Agency (EMA) the authority to more quickly authorize COVID-19 vaccines that have been adapted to address variants of the virus.   “We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus,” said European Commission President Ursu...
  • RF Quarterly

    RF Quarterly, March 2021: Global clinical trials

    Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...