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  • Regulatory NewsRegulatory News

    MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted temporary authorization on 2 December to Pfizer and BioNTech’s mRNA-based BNT162b2 COVID-19 vaccine, vaulting ahead of regulators in the US and EU.   The temporary authorization is “batch-specific” and applies only to a single batch of the vaccine. Subsequent batches must be approved by MHRA and must meet the same authorization conditions as the initial batch. MHRA said the decision was mad...
  • Regulatory NewsRegulatory News

    Device shortage guidance gets a COVID update from FDA

    An updated guidance from the US Food and Drug Administration (FDA) clarifies how the agency is handling device shortages and cessation in manufacturing during the public health emergency of the COVID-19 pandemic.   The FDA’s Center for Devices and Radiological Health updated the guidance, entitled “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency,” so...
  • Regulatory NewsRegulatory News

    From FDA: How to conduct DDI studies with acid-reducing drugs

    A new draft guidance from the US Food and Drug Administration (FDA) addresses how to conduct drug-drug interaction studies with acid-reducing medicines that can make the gastric environment more alkaline.    Medicines such as proton pump inhibitors and histamine H2 receptor antagonists, dubbed acid-reducing agents or ARAs, are in wide use and many are available without a prescription. “ARAs can affect the solubility and dissolution characteristics of orally administere...
  • RoundupsRoundups
    Regulatory NewsRegulatory News

    FDA Approvals Roundup: Imcivree, Danyelza, Ga 68 PSMA-11

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Imcivree okayed as first therapy for managing obesity in some rare genetic conditions Rhythm Pharmaceutical’s Imcivree (setmelanotide) has been approved for chronic weight management in patients aged 6 years or older with obesity related to three rare genetic conditions.   Imcivree is the first treatment approved for pro-opiomelanocortin...
  • ReconRecon

    Recon: UK approves Pfizer-BioNTech COVID vaccine; Hahn says vaccine approval possible by mid-December

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA chief Hahn says mid-December vaccine approval just 'possible': ABC News ( Reuters ) Hahn downplays White House meeting on vaccines ( The Hill ) Trump to FDA: Why is Europe beating us on vaccine? ( Politico ) UK's Pfizer vaccine approval should reassure Americans: US health chief ( Reuters ) Moderna CEO expects emergency use nod for COVID-19 vaccine shortl...
  • Regulatory NewsRegulatory News

    ACIP: First, vaccinate health care workers, nursing home residents

    In a 13-1 vote, the vaccines advisory committee of the Centers for Disease Control and Prevention (CDC) has voted to allocate the first rounds of COVID-19 vaccines to health care workers and residents of long-term care facilities.   “We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over finally,” said CDC’s Nancy Messonier, MD, director of the National Center for Immunization and Respiratory Disease...
  • Regulatory NewsRegulatory News

    Pfizer, Moderna apply for EMA authorization; Janssen's candidate begins rolling review

    Two vaccines against COVID-19 are under consideration for conditional marketing authorization by the European Medicines Agency (EMA), and a fourth vaccine candidate has entered the regulator’s rolling review process.   The European regulator could deliver an opinion on applications “within weeks” for the two messenger RNA (mRNA) vaccines developed by collaborations between Pfizer and BioNTech and between Moderna and the National Institutes of Health .   “Such a ...
  • Regulatory NewsRegulatory News

    EC names fifth notified body for IVDR

    The European Commission (EC) has announced designation of a fifth notified body for the European Union In Vitro Diagnostic Regulation (IVDR). TÜV Rheinland, the new notified body, was also designated a notified body for the upcoming Medical Device Regulation (MDR) in 2019. (Related: TÜV Rheinland becomes 5th notified body designated under MDR , Regulatory Focus 26 September 2019)   Implementation of MDR has been delayed by a year to May 2021 because of concerns abou...
  • Regulatory NewsRegulatory News

    Eudamed launched with actor registration module live

    The European Commission’s Eudamed database, a critical component of the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched on Tuesday with the actor registration module available to member states and economic operators.   “Eudamed will provide a living picture of the lifecycle of medical devices that are made available in the [EU],” the Commission writes, noting that the aim of the database is to increase transparency for medi...
  • Feature ArticlesFeature Articles

    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...
  • RoundupsRoundups

    Asia-Pacific Roundup: PMDA puts patients at heart of push for Japan-first approvals

    The head of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has outlined plans to get patients and the public more involved in product development. Chief executive Fujiwara Yasuhiro framed the initiative as part of an effort to increase the number of products that come to market in Japan before being authorized overseas.   Yasuhiro took over as chief executive of PMDA in April 2019. The following month, PMDA established the Patient Centricity Working Group to...
  • ReconRecon

    Recon: Hahn called to White House; Amgen, UCB and Takeda drugs enter new COVID trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US ready for 'immediate mass shipment' of COVID-19 vaccines: agency ( Reuters ) First US COVID-19 shots could be given 24-to-48 hours after FDA nod: health official ( Reuters ) FDA chief called to West Wing ( Axios ) ( CNN ) Regeneron, UPenn to use gene therapy tools to deliver a COVID-19 antibody drug ( BioPharmaDive ) White House to host Covid-19 vaccine su...