• ReconRecon

    Recon: Califf nomination timeline slips after Biden admin misses paperwork deadline; Canada fully approves J&J COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA nomination slips after Biden admin fails to send papers to Congress ( Politico ) Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies ( STAT ) FDA Approves Takeda's drug for post-transplant CMV infection ( Reuters ) ( FDA ) CVS, Walgreens and Walmart Fueled Opioid Crisis, Jury Finds ( NYTimes ) Elizabeth Holmes Points Finge...
  • RoundupsRoundups

    FDA Approvals Roundup: Voxzogo, Fyarro, Livtencity

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).    New approvals   Voxzogo cleared  as growth-improvement therapy for children with dwarfism   BioMarin’s  Voxzogo (vosoritide injection) has been  approved  for improv ing growth in children aged 5 years or older with achondroplasia and open epiphyses, or growth plates.    Achondroplasia is the most common form of dwarfism. Children with open  epiph...
  • Regulatory NewsRegulatory News

    Smiths Medical warned by FDA for multiple violations

    The US Food and Drug Administration (FDA) slapped Smiths Medical in Minneapolis, MN with a warning letter for inadequate procedures for handling medical device reports (MDRs), faulty handling of complaints, inadequate validation processes, and lax corrective and preventative actions (CAPA) procedures. The company makes blood warmers and infusion pumps.   The warning letter was issued on 1 October and posted on 23 November. It follows a recent recall of the company’s ...
  • Regulatory NewsRegulatory News

    FDA suggests alternative approaches for nitrosamine risk assessments

    The US Food and Drug Administration (FDA) has suggested that manufacturers consider using certain antioxidants or excipients, such as sodium carbonate, to their drug products to inhibit the formation of nitrosamine impurities.   These approaches were outlined in recent update on possible mitigation strategies to reduce the risk of nitrosamine impurities in drug products. The update was prompted by reports of certain types of nitrosamine impurities that formed in “sever...
  • Regulatory NewsRegulatory News

    FDA shares research to improve dose selection in pediatric drug development

    Dose selection is a significant challenge in pediatric drug development; commonly used renal function equations can overestimate glomerular filtration rates and result in inaccurate predictions of drug elimination.   In a Regulatory Science in Action article , scientists from the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) shared findings about how adjustments to the estimated glomerular filtration rate (eGFR) equations could help ...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA changes medicinal cannabis approval process, plans further reforms

    The Therapeutic Goods Administration (TGA) has revised the process for applying to supply medicinal cannabis products under Australia’s Special Access Scheme (SAS) and Authorised Prescriber scheme. TGA made the changes after holding a consultation that also convinced it of the need for other, more substantive reforms of the approval process.   In the first set of changes, which took effect on Monday, TGA dropped the need to file Therapeutic Goods (Standard for Medicina...
  • ReconRecon

    Recon: Global license deal to provide COVID antibody test tech free to poorer countries; GSK partners with Arrowhead for NASH drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Elizabeth Holmes’ defense lets Theranos founder play role of young do-gooder in second day on stand ( CNBC ) ( Law360 ) Holmes to take stand for third day in Theranos fraud trial ( Reuters ) Why You Can’t Find Cheap At-Home Covid Tests ( KHN ) GSK dives into NASH, RNA interference with Arrowhead deal ( BioPharmaDive ) Califf’s profitable industry ties spark f...
  • Regulatory NewsRegulatory News

    FDA says it far exceeded its projections for inspections in FY2021

    In an update to its Resiliency Roadmap for FDA Inspectional Oversight , the US Food and Drug Administration (FDA) on Monday said that the number of domestic surveillance inspections it carried out in the second half of FY2021 was more than double the number it initially projected in the roadmap last spring.   In its initial Roadmap, FDA estimated that more than 15,000 domestic surveillance inspections that it planned to complete in FY2020 and FY2021 were postponed due...
  • Regulatory NewsRegulatory News

    EMA provides advice on using molnupiravir; will soon render decision on J&J’s COVID vaccine booster

    The European Medicines Agency (EMA) on 19 November issued advice to member states on how to use Merck Sharp & Dohme’s and Ridgeback Biotherapeutics’ antiviral drug Lagevrio (molnupiravir), an oral antiviral drug for treating patients with COVID-19, prior to its formal EU authorization. This action was taken to combat “rising rates of infection and deaths due to COVID-19 across the EU," EMA said.   In related developments, the European regulator also announced that it...
  • Feature ArticlesFeature Articles

    Recent FDA approvals of drugs and biologics for children

    This article provides a summary of drugs and biologic products that have recently become available for the pediatric population in the United States. It highlights prescription products for attention deficit hyperactivity disorder (ADHD), psoriasis, active polyarticular juvenile idiopathic arthritis (pJIA), active psoriatic arthritis, Ebola virus treatment, spinal muscular atrophy, and bladder dysfunction that became available in 2019, 2020, and 2021 after completion of pe...
  • Regulatory NewsRegulatory News

    GAO: Pathway for antimicrobial drug development leads to few approvals

    A regulatory pathway to encourage development of drugs to combat antimicrobial resistant infections – the limited population pathway for antibacterial and antifungal drugs (LPAD) – has resulted in just two drug approvals by the US Food and Drug Administration (FDA) since 2016, according to a new report from the Government Accountability Office (GAO).   The GAO report , released on 19 November 2021, suggested that the LPAD pathway does not address the underlying econom...
  • ReconRecon

    Recon: Pfizer touts long-term efficacy data for COVID vaccine in adolescents; House panel seeks interview with Hahn

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC expands eligibility for Covid-19 booster shots to all adults ( STAT ) Johnson & Johnson touts ‘golden moment’ to pursue pharma-led future ( FT ) Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug ( NYTimes ) Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy ( BioPharmaDive ) CBO: Democrats' package ...