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  • Regulatory NewsRegulatory News

    MDCG offers guidance on safety reporting for device studies under MDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Wednesday released a new guidance explaining how safety reporting in clinical investigations of medical devices should be performed under the Medical Devices Regulation (MDR).   The guidance comes after both the date of application of the MDR and the launch of Eudamed were delayed by one and two years, respectively. (RELATED: MDR delay official as industry calls to push back IVDR , Regulatory F...
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    FDA updates guidance on clinical trials amid COVID-19

    The US Food and Drug Administration (FDA) this week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address new questions, including the use of alternate laboratory or imaging centers, video conferencing and postmarketing requirements.   The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take...
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    Refine gene therapy follow-up guidance, expert says

    It’s time for regulatory agencies, academics and pharmaceutical companies to convene to refine guidance for long-term follow-up of patients receiving gene therapy. That was the message Anne-Virginie Eggimann, senior vice president for regulatory science at bluebird bio, Inc., brought to a policy session at the annual meeting of the American Society of Gene & Cell Therapy .   To date, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) hav...
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    FDA issues two guidances to accelerate COVID-19 treatments

    The US Food and Drug Administration (FDA) on Monday evening issued two guidances intended to accelerate the development of products to treat or prevent coronavirus disease (COVID-19), laying out recommendations to help companies get to the investigational new drug application (IND) stage and clinical trial design considerations for later-stage studies.   “Accelerating the investigation of safe and effective therapies that could benefit people affected by the COVID-19 p...
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    FDA plans phased approach to restarting surveillance inspections

    After halting most foreign and domestic inspections in March due to the coronavirus disease (COVID-19) outbreak, the US Food and Drug Administration on Monday said it is working with the Centers for Disease Control and Prevention (CDC) on a phased plan for resuming on-site surveillance inspections.   In March, FDA said it would halt foreign inspections and domestic routine surveillance inspections and would only conduct “mission-critical” foreign or domestic for-cause ...
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    Purple Book: FDA adds transition biologics as move to single database progresses

    The US Food and Drug Administration (FDA) on Monday updated its searchable Purple Book database to include all biologics regulated by its Center for Drug Evaluation and Research (CDER) with the addition of products that transitioned from new drug applications (NDAs) to biologics license applications (BLAs) last March.   With the update, FDA also added the ability to download monthly reports that include a changelog detailing new and updated products from the previous...
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    FDA authorizes first antigen test for COVID-19, updates EUA templates

    After issuing an emergency use authorization (EUA) for the first antigen test for coronavirus disease (COVID-19) over the weekend, the US Food and Drug Administration (FDA) on Monday updated its EUA templates for molecular diagnostics and posted a new EUA template for antigen test developers.   On Saturday, FDA announced it had issued an EUA to Quidel Corporation for its Sofia 2 SARS Antigen FIA test to detect SARS-CoV-2 antigens from nasopharyngeal and nasal swab spec...
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    Remdesivir: EMA recommends wider compassionate use

    The European Medicines Agency (EMA) on Monday recommended expanding compassionate use programs for Gilead Sciences’ investigational drug remdesivir to treat coronavirus disease (COVID-19) patients who are not on mechanical ventilation and to allow for a shorter treatment duration based on the results of two recent clinical studies.   In early April, EMA released its initial recommendations for providing remdesivir through compassionate use programs for patients who are...
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    EMA preparing big data Q&A guidance

    The European Medicines Agency (EMA) says it is preparing a question and answer guidance on the application of EU data protection rules to the secondary use of health data in medicines development, evaluation and supervision.   EMA explains that secondary use of data describes “the use of data for a different purpose than the one for which it was originally collected,” and applies to various real-world data sources such as electronic health records, health insurance cla...
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    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...
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    FDA issues EUA for saliva-based COVID-19 test, provides path for wider home sample collection

    The US Food and Drug Administration (FDA) on Friday granted the first emergency use authorization (EUA) allowing for at-home saliva sample collection for a coronavirus disease (COVID-19) diagnostic and opened the door to wider at-home sample collection.   EUA   The EUA allows Rutgers Clinical Genomics Laboratory to use its TaqPath SARS-CoV-2 Assay, which was previously covered under the umbrella EUA for laboratory developed tests (LDT) for COVID-19, to test home co...
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    GAO finds HHS not using new authority for hiring top scientists at FDA, NIH

    The Department of Health and Human Services (HHS) has not used new authorities granted under the 21 st Century Cures Act to recruit and retain senior scientists to the department or its sub-agencies, including the Food and Drug Administration (FDA) and National Institutes of Health (NIH), the Government Accountability Office said in a report published Friday.   Specifically, the report looked at HHS’ implementation of Section 3071 of the Cures act, which expanded ...