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  • Regulatory NewsRegulatory News

    FDA addresses endotoxin levels in investigational cancer treatments

    Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the US Food and Drug Administration.   The draft guidance addresses the reality of oncologic drug development, where investigational therapies are frequently used in combination with other approved treatments, or in conjunction with another investigational drug. Specifically addressed are parenterally admi...
  • Feature ArticlesFeature Articles

    Designing a biologics manufacturing facility: Early planning for success

    This article reviews important steps in the manufacture of biologics. The authors provide planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC). They pose important questions manufacturers should address, from facility issues to working with a contract development manufacturing organization. They conclude that trends toward reducing the time to market put considerable stress on all aspect...
  • Regulatory NewsRegulatory News

    Six more months tacked onto regenerative medicine enforcement date

        The end of a discretionary enforcement period for regenerative medicine products was pushed back by another 6 months, according to a final guidance issued today by the US Food and Drug Administration (FDA).   Today’s updated guidance shifts the enforcement date but otherwise leaves unchanged a 2017 guidance addressing regulatory considerations for “minimal manipulation” and “homologous use” of human cells, tissues and cellular and tissue-based products (HCT/P...
  • Regulatory NewsRegulatory News

    CBER withdraws 20 draft and final guidances

    Last week, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) withdrew 20 draft and final guidances, more than half of which date back to the 1980s and 1990s.   Many of the withdrawn guidances relate to blood and blood products, donor screening and HIV. Among the guidances are a Y2K-era guidance on handling the year 2000 date change for computer systems and software applications used to manufacture blood products and a 200...
  • Regulatory NewsRegulatory News

    No COVID claims for exosome product, warns FDA

    A firm that manufactures human stem cell and exosome products was cited by the US Food and Drug Administration (FDA) for marketing an exosome product to treat or prevent the novel coronavirus, COVID-19 without premarket review or approval.   In the warning letter dated June 4, FDA quoted EUCYT Laboratories’ website, which claimed that “COVIXO drives cellular functionality including augmenting the type 1 interferon pathway ... that is important for anti-SARS-CoV-2 act...
  • 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...
  • Regulatory NewsRegulatory News

    EMA official says COVID-19 vaccine could be approved in a year

    A vaccine against SARS-CoV-2, the novel coronavirus scourging the globe, could be approved in the European Union in about a year, Marco Cavaleri, the European Medicines Agency’s top official overseeing anti-infectives and vaccines, said Thursday.   Cavaleri cautioned that this is an optimistic view but said the ambition is to have a vaccine approved next Spring and that he is skeptical of claims that a vaccine could be ready by September .   “I have to stress that...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Regulators urge RCTs with control arms for COVID-19 drug trials

    As no specific therapeutic has clearly demonstrated efficacy for treating COVID-19, more than two dozen pharmaceutical regulators around the world agreed in a virtual workshop last week that randomized controlled trials (RCTs), long considered the gold standard for clinical trials, will be necessary for approvals. The summary report of the meeting also stressed the need for COVID-19 drug developers to include an appropriate control arm (“i.e. not including antivirals or...
  • Regulatory NewsRegulatory News

    PDUFA, BsUFA resource capacity planning: Report recommends refinements

    A new report from Booz Allen Hamilton commissioned by the US Food and Drug Administration (FDA) recommends refinements to the agency’s workload capacity planning adjustment methodology for its prescription drug (PDUFA VI) and biosimilar (BsUFA II) user fee programs.   Background   A workload adjustment mechanism was first introduced under PDUFA III, as “a means to adjust the annual PDUFA target revenue to account for long-term changes in the volume of certain regul...
  • Regulatory NewsRegulatory News

    FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics

    The US Food and Drug Administration (FDA) on Thursday proposed a new rule to allow certain biologics, originally approved under a new drug application (NDA), to continue relying on drug master files (DMFs) for certain information even after the NDA is deemed to be a license for a biological product on 23 March 2020. This so-called “deemed to be a license” transition next year, the details of which were explained in full last December, will mean that moving forward, fo...
  • Regulatory NewsRegulatory News

    FDA Proposes to Remove Mycoplasma Test Method

    The US Food and Drug Administration (FDA) issued a proposed rule on Monday to remove the required testing method to detect the presence of Mycoplasma because FDA said the regulation is restrictive in that it identifies only one test method to be used even though other methods may be appropriate. The proposed rule seeks to remove the testing method for Mycoplasma detection in virus harvest pools and control fluid pools of live and inactivated virus vaccines produced ...