• Regulatory NewsRegulatory News

    FDA warns COVID trial sponsor for failing to submit IND

    The US Food and Drug Administration (FDA) last month warned a clinical trial sponsor for failing to submit an investigational new drug (IND) application for a study of a product to treat COVID-19.   In its warning letter to KDunn and Associates, P.A. dba HealthQuilt, FDA said it observed “objectionable conditions” during an August inspection related to a trial the company sponsored titled “An Open-Label Pilot Study to Assess the Efficacy and Safety of [redacted] in Sub...
  • Regulatory NewsRegulatory News

    EMA sets 12 March J&J vaccine meeting; Celltrion's mAb gets Article 5(3) review

    The European Medicines Agency (EMA) has announced an extraordinary meeting of its human medicines committee (CHMP) to evaluate the COVID-19 vaccine developed by Janssen, a Johnson & Johnson division. The aim of the 11 March meeting will be to “conclude the evaluation, if possible.”   The US Food and Drug Administration issued an emergency use authorization for the one-shot adenovirus vaccine on 27 February after its vaccines advisory committee voted unanimously that ...
  • Regulatory NewsRegulatory News

    EMA, Health Canada publish Moderna data package

    Making good on an earlier commitment to transparency in regulatory decision-making during the COVID-19 pandemic, the European Medicines Agency (EMA), in collaboration with Health Canada, has published the full clinical data package upon which the regulators based their approvals of the COVID-19 vaccine jointly developed by Moderna and the US National Institutes of Health.   The Tuesday announcement of the availability of the data package “highlights the shared commitme...
  • ReconRecon

    Recon: Merck to manufacture J&J COVID vaccine; Merck withdraws Keytruda for third-line SCLC

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck to help make Johnson & Johnson's COVID-19 vaccine: White House official ( Reuters ) ( Politico ) ( WaPo ) J&J COVID-19 vaccine shipping to US, but new deliveries hinge on regulators ( Reuters 1 , 2 ) US downplays possibility of sharing COVID-19 vaccines with Mexico ( Reuters ) Fauci says US must stick to two-shot strategy for Pfizer, Moderna vaccines: p...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA seeks feedback on nanomaterial in medical device regulations

    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on the introduction of specific requirements for medical devices containing nanomaterials. TGA is considering adding new definitions and amending essential principles or creating new classification rules.   Materials that range from 1 to 100 nanometers in size are typically considered to be nanomaterials. There are concerns about the impacts of such materials on health and the environment. Tho...
  • Regulatory NewsRegulatory News

    Global medicinal supply chain examined in EC, US efforts

    The European Commission has launched a structured dialog addressing pharmaceutical supply chain initiatives, aiming to safeguard the security of the European Union’s supply of medicines. A 26 February launch meeting kicked off the structured dialog initiative, which brings together national authorities, patients, nongovernmental organizations working in the health sector and members of the research community.   By coming to a clearer understanding of how global medical...
  • Regulatory NewsRegulatory News

    MDCG issues guidance on Eudamed alternatives

    The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance on administrative practices and alternative technical solutions on the application of certain Medical Device Regulation (MDR) provisions in the absence of a fully functional Eudamed system.   While the first of six Eudamed modules was made available late last year, the remaining modules are expected to be rolled out by the database’s May 2022 date of application. Some modules, ...
  • Feature ArticlesFeature Articles

    February's Regulatory Focus: Global and regional harmonization and alignment

    Feature articles during February included a range of topics focused on harmonization and alignment across global and regional regulatory entities, including electronic submissions through the European Medicines Agency (EMA), tools for updating the EU In Vitro Diagnostic Regulation (EU IVDR) template, China’s new PAC regulation, Project Orbis and improving patients access to new therapies, as well as a report on medtech companies’ preparation for EU Medical Device Regulatio...
  • Regulatory NewsRegulatory News

    FDA on Rare Disease Day: New initiatives and an upcoming conference

    On Monday, the US Food and Drug Administration (FDA) announced a series of efforts and a day-long conference centered on addressing the unmet needs of patients with rare diseases. FDA leaders announced the initiatives in recognition of Rare Disease Day, observed on February 28.   A new request for applications (RFA) issued by FDA augments the agency’s Orphan Products Grants Program. The RFA is seeking natural history studies to address unmet needs in rare diseases, l...
  • Feature ArticlesFeature Articles

    Project Orbis: Maximizing patient access to new medicines

    To ensure equitable access to new medicines for all patients, drug manufacturers aim to register new products in as many countries as possible. Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), is a pilot program that provides applicants with a framework for concurrent submission and review of oncology products among international partners to allow earlier registration in countries outside of the US. This article summarizes Genentech’s experience...
  • ReconRecon

    Recon: Merck signs €900M deal for Debiopharm for cancer drug; Perrigo to sell generic business for $1.55B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA authorizes Johnson & Johnson’s single-dose Covid-19 vaccine ( STAT ) ( Reuters ) ( Politico ) ( FDA ) Single-dose Covid vaccine recommended by CDC advisory panel ( Politico ) J&J CEO sees COVID-19 shots in American arms in 1-2 days as shipping starts ( Reuters 1 , 2 ) Johnson & Johnson has planned trials of its vaccine that will include infants ( NYTimes ...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. A dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in early deve...