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  • Regulatory NewsRegulatory News

    Rituximab biosimilar prequalified by WHO

    The World Health Organization (WHO) has prequalified South Korean drugmaker Celltrion’s biosimilar version of rituximab, the second product achieving that status under a biosimilar prequalification pilot begun by the agency in 2018.   “Rituximab has revolutionized the treatment of diffuse large B-cell lymphoma, chronic lymphocytic leukemia and follicular lymphoma, significantly improving therapeutic responses, and remains a fundamental component of treatment regimens...
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    European Commission updates on MDR, IVDR implementation timeline

    The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   The update follows the move to delay the implementation of MDR by one year due to the coronavirus disease (COVID-19) pandemic and the decision to delay Eudamed’s rollout by two years last December. (RELATED: MDR delay official as industry calls to push back IVDR , ...
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    PIC/S adopts cross-contamination, HBEL guides

    Following their adoption last month, two new Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance documents entered into force this week, a questions and answers guidance on implementing risk-based prevention of cross-contamination and an aide-memoire on health-based exposure limit (HBEL) assessments.   Both documents were adopted on 22 May 2020 following development and review by the PIC/S Expert Circle and entered into force on 1 June 2020.   The firs...
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    FDA releases compliance program for CDER, CDRH-led combination product inspections

    In a newly issued compliance program , the US Food and Drug Administration (FDA) explains its approach to inspections of Center for Drug Evaluation and Research (CDER)- and Center for Devices and Radiological Health (CDRH)-led combination products.   The 46-page document lays out FDA’s intended implementation of the compliance program; inspectional operations and reporting considerations; sampling and analytical testing expectations; regulatory and administrative stra...
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    E-signatures clarified in FDA’s COVID-19 clinical trial guidance

    The US Food and Drug Administration (FDA) updated its guidance regarding informed consent for clinical trials during the coronavirus public health emergency to add information about electronic signatures for informed consent, and to provide clarification about remote assessments during clinical trials.   In its announcement regarding the updates, FDA said that it issued the guidance “because we recognize that the COVID-19 public health emergency may impact the conduc...
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    FDA defends its oversight of foreign drugs amid Senate, GAO criticism

    During a Senate Committee on Finance hearing Tuesday, officials from the US Food and Drug Administration (FDA) responded to criticism from senators and a new report from the Government Accountability Office (GAO) on its oversight of foreign drug manufacturers.   The hearing follows FDA’s move to halt most foreign inspections in March as a result of the coronavirus disease (COVID-19) pandemic. (RELATED: Coronavirus prompts FDA to cancel travel, postpone inspection...
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    FDA eases IRB review of COVID-19 expanded access requests

    Institutional review boards (IRBs) may establish procedures to have a single IRB member review individual patient expanded access requests for investigational drugs and biologic products to treat coronavirus disease (COVID-19), says new guidance from the US Food and Drug Administration (FDA).   The guidance provides clarification for IRBs that may be seeing increased numbers of individual patient expanded access requests related to COVID-19 infection.   In light ...
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    Antimicrobial approvals are not bottlenecked by FDA

    Sponsors seeking US Food and Drug Administration (FDA) approval for antimicrobial drugs accessed expedited clinical testing and review programs at least as frequently as those seeking approval of non-antimicrobials, according to a study published Tuesday in The Lancet Infectious Diseases . The median time from investigational new drug (IND) application to drug approval was shorter for antimicrobials than other drugs.   “We did not find evidence that antimicrobial de...
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    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...
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    ICH updates on upcoming guidelines, adds new participants

    The International Council for Harmonisation (ICH) on Wednesday announced the addition of a new member and observer to its ranks and updated on the progress of guidelines in development following a virtual meeting of the ICH Assembly last week held in lieu of its previously scheduled meeting in Vancouver, Canada.   At the meeting, ICH welcomed Turkey’s Medicines and Medical Devices Agency (TITCK) as a regulatory member, after having joined ICH as an observer in 2018...
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    FDA issues 69 new and revised draft product-specific guidances

    The US Food and Drug Administration (FDA) on Wednesday released 26 new and 43 revised draft product-specific guidances to support the development of generic drugs.   The guidances , when finalized, are intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, FDA has issued a total of 1,903 product-specific guidances.   The latest bat...
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    Canada’s drug price reforms delayed to 2021

    Amendments to Canada’s Patented Medicines Regulations will now be put in place 1 January 2021, delaying implementation of the sweeping drug pricing reforms by six months.   The new timeline represents a further adjustment from the schedule laid out in 2017, when Health Canada first proposed overhauling its drug pricing review process.   Draft pricing guidelines promulgated by the government of Canada’s Patent Medicine Prices Review Board (PMPRB) have been availab...