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  • RoundupsRoundups

    FDA Approvals Roundup: Tauvid, Oriahnn, Sirturo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tauvid nabs approval as first drug to aid imaging of tau pathology FDA has approved Avid Radiopharmaceuticals’ radioactive diagnostic agent Tauvid (flortaucipir F18 injection) as the first drug to image tau pathology, a distinctive characteristic of Alzheimer’s disease in the brain.   The drug is indicated for intravenous administration bef...
  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Regulatory NewsRegulatory News

    New approvals and indication from FDA: Alunbrig, VESIcare LC, Kynmobi and more

    This is the first in a series of weekly roundups of new drug approvals and indications from the US Food and Drug Administration (FDA).   Alunbrig gets new indication as first-line therapy for ALK-positive metastatic NSCLC On 22 May, FDA approved a new indication for Takeda’s Alunbrig (brigatinib) as a first-line treatment for adults with anaplastic lymphoma kinase‒positive metastatic non‒small cell lung cancer (NSCLC). The agency also approved a companion diagnost...
  • Regulatory NewsRegulatory News

    Notable approvals: FDA okays Tabrecta, adds indication for Farxiga

    The US Food and Drug Administration (FDA) on Wednesday granted accelerated approval to Novartis Pharmaceuticals’ Tabrecta (capmatinib) as the first targeted therapy for adults with metastatic non-small cell lung cancer (NSCLC) who have mutations that drive mesenchymal-epithelial transition (MET) exon 14 skipping. The drug inhibits MET tyrosine kinase, an enzyme associated with cancer cell growth and metastasis.   The agency also approved FoundationOne CDx assay (F1CD...
  • Feature ArticlesFeature Articles

    EU device regulations, COVID-19 response and global regulatory strategy

    Feature articles during April focused predominantly on the new European Medical Devices Regulation ( EU MDR ), In Vitro Diagnostic Medical Devices Regulation ( EU IVDR ) and the COVID-19 pandemic, with a number of regulatory experts examining the impact of pandemic-related delays on the progression of the European regulations. Also included were articles on the European Database on Medical Devices (Eudamed), the Mutual Recognition Agreement (MRA) between Switzerland an...