• Regulatory NewsRegulatory News

    FDA adcomm unanimous on J&J boosters for all

    The vaccines advisory committee of the US Food and Drug Administration (FDA) voted unanimously Friday to recommend a full-strength booster dose of the COVID-19 vaccine made by Janssen, the vaccines arm of Johnson & Johnson, for all recipients of the single-dose primary vaccination.   The Vaccines and Related Biologic Products advisory committee (VRBPAC) recommended that FDA issue an emergency use authorization (EUA) for a booster to be given at least 2 months after the...
  • Regulatory NewsRegulatory News

    CHMP recommends 6 medicines for authorization, Incyte pulls application for Zynyz

    The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) this week recommended six new medicines for marketing authorization in the EU.   The recommendations include positive opinions for four medicines and one generic, as well as conditional authorization for Janssen's Rybrevant (amivantamab) for the treatment of non-small cell lung cancer with activating epidermal growth factor receptor exon 20 insertion mutations.   The recomme...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost two 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 vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that are au...
  • ReconRecon

    Recon: Bayer, CureVac end vaccine production partnership; FDA calls advisory committee to discuss Merck's COVID drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA advisers to vote on J&J vaccine booster ( Reuters ) FDA advisers back Moderna COVID booster shots for older and high-risk people ( Reuters ) ( NYTimes ) Abbott Labs unit recalling two COVID-19 lab test kits – FDA ( Reuters ) As suits mount, J&J spins out talc liabilities into Chapter 11 using 'Texas two-step' maneuver ( Endpoints ) ( FT ) FDA to Hold...
  • Regulatory NewsRegulatory News

    FDA nixes GUDID submission requirements for class I consumer healthcare devices

    Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) submission requirements under a draft guidance issued on Wednesday.   Under the agency's unique device identification (UDI) compliance policy guidance issued in June 2020, class I devices, other than implantable, life-supporting, and life-sustaini...
  • Regulatory NewsRegulatory News

    Unanimous thumbs up from FDA committee for Moderna booster

    An advisory committee to the US Food and Drug Administration (FDA) voted unanimously to recommend a half-strength booster dose of the mRNA COVID-19 developed by Moderna and the National Institutes of Health for those 65 years and older, and for certain younger populations at high risk of severe COVID-19.   Moderna has requested an emergency use authorization (EUA) for the 50 mcg booster dose for individuals who have already completed the two-dose series of the Moderna ...
  • Regulatory NewsRegulatory News

    IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage

    Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to delay the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR).   The medical device industry has long pushed for the EU to delay IVDR, warning that the new regulation is more disruptive to the market for diagnostics than its counterpart Medical Devices Regulation (MDR), which itself was delay...
  • Regulatory NewsRegulatory News

    Euro Roundup: EMA warns action against titanium dioxide will cause significant drug shortages

    The European Medicines Agency (EMA) has found that requiring manufacturers to replace titanium dioxide (TiO2) in medicines “will almost certainly cause significant medicines shortages and discontinuations/withdrawals ... with major implications for patients and animals.”   EMA investigated the impact of phasing out the use of the excipient at the request of the European Commission. The Commission’s request was triggered by a European Food Safety Authority (EFSA) recomm...
  • ReconRecon

    Recon: White House reportedly eyeing Califf as FDA commissioner; EU kicks off review of AstraZeneca COVID antibody cocktail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House zeroes in on Califf to head FDA as deadline nears ( Washington Post ) U.S. FDA advisers weigh case for COVID-19 vaccine booster shots ( Reuters ) ( STAT ) J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study ( Reuters ) ( NBC ) Data from Federal Scientists Raise Questions About J.&J. Booster Shots ( NYTimes ) Biden official warn...
  • Regulatory NewsRegulatory News

    IT and staffing issues impeded CDRH pandemic test response: Report

    Lagging information technology infrastructure, inefficient staffing, and validation methods that were not set up for a pandemic were among the weaknesses identified by an outside assessment of the U.S. Food and Drug Administration’s (FDA's) handling of COVID-19 diagnostic test emergency use authorizations (EUAs) during the pandemic.   The independent report, conducted by the consulting firm Booz Allen Hamilton at the request of FDA's Center for Devices and Radiological...
  • RoundupsRoundups

    FDA Approvals Roundup: Tavneos, Verzenio, Dextenza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tavneos okayed for ANCA-associated vasculitis ChemoCentryx’s Tavneos (avacopan) has been approved as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, also known as ANCA-associated vasculitis, in combination with standard therapy.   ANCA-associated vasculitis is a group of thr...
  • Regulatory NewsRegulatory News

    FDA warns companies for GMP violations, conducting trial without IND

    A contact testing laboratory found in violation of Current Good Manufacturing Practice (CGMP) regulations and a nutritional supplement company conducting a clinical investigation without an investigational new drug application (IND) have been sent warning letters by the US Food and Drug Administration (FDA).   FDA sent Missouri Analytical Laboratories Inc. a warning letter on 30 September due to “significant violations” of CGMP and “significant deviations from CGMP" fo...