• Regulatory NewsRegulatory News

    FDA Warns Genetic Testing Lab in Virginia

    The US Food and Drug Administration (FDA) on Thursday sent a warning letter to Falls Church, VA-based Inova Genomics Laboratory, raising concerns about the clinical validity of several genetic tests offered by the lab. Inova markets genetic tests for “predicting medication response, reducing negative side effects from certain medications, discovering the right drug and right dose for a patient, and avoiding trial-and-error prescribing by healthcare providers by testing ...
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    Pfizer Uses EHR Data to Support Expanded Indication for Breast Cancer Drug

    In a move that may become more common as the US Food and Drug Administration’s (FDA) comfort with real-world data (RWD) increases, FDA on Thursday approved a new indication for Pfizer’s Ibrance (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with certain types of metastatic breast cancer. The approval is based on RWD from electronic health records and postmarketing reports of Ibrance in male patients sourced from three databases: I...
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    FDA Identifies ARBs Without Impurities

    For the first time since the US Food and Drug Administration (FDA) discovered a nitrosamine impurity in angiotensin II receptor blockers (ARBs) last summer, the agency has now identified 40 ARBs and counting that do not contain a nitrosamine impurity. “Our goal is for this information to help health care providers as they consider acceptable treatment options for their patients,” outgoing FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock said in a joint s...
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    Canada and France Suspend Sales of Certain Breast Implants Linked to Cancer

    France’s National Agency for the Safety of Medicines and Health Products (ANSM) on Thursday announced that sales of macro-textured breast implants and polyurethane-coated breast implants will be suspended, while Health Canada, also on Thursday, announced that it intends to halt sales of Allergan’s Biocell breast implant. Both decisions are related to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). In Canada, the decision follows the r...
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    When a REMS is Necessary: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance from 2016 detailing the factors that the agency uses to determine whether a risk evaluation and mitigation strategy (REMS) is necessary for a drug. As defined by the guidance, a REMS is a required risk management plan that can include one or more elements to ensure that the benefits of a drug outweigh its risks. Such elements can include a medication guide, a package insert or a communication plan ...
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    House E&C Passes CREATES, Pay-for-Delay Bills

    The House Energy & Commerce Committee late Wednesday passed five bills related to generic drug competition, two of which were slightly tweaked to make them bipartisan. Passed by a unanimous 51-0 vote, HR 965 , the "Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019," introduced by six representatives on both sides of the aisle, would establish a process by which generic manufacturers can obtain sufficient quantities of brand drug samples fo...
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    Health Canada Implements ICH Guideline on Good Clinical Practice

    Health Canada said Wednesday that it has implemented the International Council for Harmonisation’s (ICH) guideline on good clinical practice, known as E6(R2). While working to eliminate the differences between its own and ICH guidances, Health Canada said that in cases of such discrepancies, Health Canada-implemented ICH guidances should take precedence. The decision to implement the guideline in Canada follows the work of its ICH peer regulatory agencies to implemen...
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    Industry Calls on FDA to Streamline Process of Providing Marketing Status Updates

    Industry groups PhRMA and the Association for Accessible Medicines (AAM), as well as companies Pfizer and Teva Pharmaceuticals are calling on the US Food and Drug Administration (FDA) to tweak and clarify recently drafted guidance on marketing status updates. The draft guidance from January helps sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they have to share with FDA on the marketing status of thei...
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    MHRA Offers Additional No-Deal Brexit Guidance

    As a no-deal Brexit appears increasingly likely to occur on 12 April, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday released further guidance for biopharma companies related to substantial amendments to a clinical trial, updated guidance on applying to release a vaccine or a blood product and an updated webinar on making submissions via MHRA Submissions. The guidance on clinical trials makes clear that in the event of a no-deal Brexit,...
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    Six Lawsuits Target AbbVie’s Humira and its Patent Thicket

    The city of Baltimore, the largest grocery-worker union in New York and at least four other health plans have filed lawsuits against AbbVie over the past several weeks, alleging the Chicago-based company’s blockbuster Humira (adalimumab) should already have biosimilar competition in the US. One of the lawsuits, brought on by UFCW Local 1500 Welfare Fund, the New York grocery-worker union, argues that AbbVie should be held accountable for its thicket of patents and recen...
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    Teva, Pfizer Seek Clarity on Tentative ANDA Approval Draft Guidance

    With the overall goal of reducing the number of complete response letters (CRLs) between tentative approval and final approval for abbreviated new drug applications (ANDAs), Teva Pharmaceuticals and Pfizer are calling on the US Food and Drug Administration (FDA) to elaborate further on some specifics in a draft guidance on tentatively approved ANDAs. The 12-page draft guidance from last January provides recommendations on the timing and content of amendments to tentat...
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    Insulin Competition: FDA to Hold Public Meeting

    As insulin products continue to remain unaffordable for many, the US Food and Drug Administration (FDA) on 13 May will hold a day-long public meeting to discuss access to insulin and issues related to the development and approval of competitor products, including biosimilar and interchangeable insulin products. "We’re already seeing robust activity among sponsors seeking to bring forward biosimilar copies of insulin. The framework for demonstrating that these insulin pr...