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    Transparency: What FDA Drug, Device Regulations are Coming Later in 2016

    As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules. By 31 March, according to the TRACK database, the agency expects to release four final rules and three propose...
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    FDA Questions How Company’s ‘Training Products’ Entered US Drug Supply Chain

    The US Food and Drug Administration (FDA) has sent untitled letters to two companies selling a medical product that is intended for training purposes only. The letters were sent more than eight months after recalling the product, which was linked to two deaths. FDA said its investigation of adverse events associated with the use of Wallcur’s “Practi-0.9% Sodium Chloride” product identified several ways in which Florida-based PSS World Medical and Connecticut-based Moore ...
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    FDA Issues Guidance on Zika in Human Cell and Tissue Products

    The US Food and Drug Administration (FDA) on Tuesday announced new measures to prevent transmission of Zika virus via human cell and tissue products (HCT/Ps) by recommending a six-month deferral for at-risk donors. The virus, which has swept across Latin America and the Caribbean, is believed to be behind a spike in cases of microcephaly, a rare condition where an infant is born with an abnormally small head, and Guillain-Barré syndrome, a neurological disorder that can ...
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    Updated: European Commission: Cranberry-Derived Products are not Medical Devices

    Updated with comment from Medical Brands' CEO. The European Commission has released a draft decision that would mean the group of products depending on proanthocyanidins present in cranberry (Vaccinium Macrocarpon) extract, in order to prevent or treat cystitis, also known as bladder inflammation or infection, should not be classified as medical devices. The need for the European Commission to make this decision on cranberry-derived products came as some companies  -...
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    Practical Guidance for Regulatory Professionals on Combination Products

    This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities. Combination Products Combining a drug, device or biological product into a new product (frequently called a "combination product") continues to be an important and growing category of therapeutic products. Approximately one-thir...
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    Swedish Regulators Halt Imports from AstraZeneca’s Indian API Plant

    European imports from AstraZeneca’s now-closed terbutaline sulphate active pharmaceutical ingredient (API) manufacturing facility in Bangalore, India were halted by Sweden’s Medical Products Agency after failed validation runs, according to a recent notice in EudraGMDP. “The concerned API-batches or finished product containing the API should not be imported to the EEA [European Economic Area],” the agency said. “All API batches manufactured during the year 2014 are conce...
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    FDA’s CBER Questions US Transplant Technology Company

    The US Food and Drug Administration (FDA) is taking issue with Arizona-based Pinnacle Transplant Technologies for manufacturing a number of proprietary amniotic membrane-based products that FDA believes should be classified and approved as biologics. Pinnacle, according to its website , currently manufactures and distributes morselized amniotic membrane-based products, which FDA says are intended to treat soft tissue injuries and inflammation, to cover and protect wou...
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    Industry, Patient Groups Weigh in on FDA's Biosimilar Naming Guidance

    Industry is calling on the US Food and Drug Administration (FDA) to use to use "meaningful" and "distinguishable" suffixes linked to a biosimilar license holder's name, according to comments on the proposed naming system. In total, FDA received 178 comments on its draft guidance, known as Nonproprietary Naming of Biological Products , including clear calls for changes to FDA's proposal. Background In August, FDA released the guidance, which proposed a naming conventi...
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    Califf Endorses Report on Combination Products Intercenter Consults

    In a letter dated Wednesday, US Food and Drug Administration (FDA) Commissioner nominee Robert Califf endorsed an internal report detailing recommendations for how FDA could improve reviews of combination products, but says that the agency is already in the midst of addressing the issues called out in the report. Background Combination products , or any products combining drugs, devices, and biologicals, create complex regulatory challenges for both FDA and their spons...
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    EMA Wants to Help Drugmakers Show Their Orphan Products' Benefits

    The European Medicines Agency (EMA) is looking help sponsors developing new orphan drugs by clearing up questions on how they can demonstrate their product's improvement over existing therapies. To do so, the agency will be hosting a workshop on 7 December 2015, where it says industry, regulators, health technology assessment (HTA) bodies and other groups will have the opportunity to discuss approaches to demonstrating "significant benefit" for orphan products. Orphan D...
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    European Commission Seeks Industry Comment on New GMP Guidelines for Investigational Drugs

    The European Commission is seeking comment from industry on two documents tied to the guidelines and principles of good manufacturing practices (GMP) for investigational drugs. The commission notes that the current GMPs for medicinal products for human use from a 2003 directive are "generally well-functioning," so, "There is no need to reinvent the wheel." The application of GMPs for investigational drugs is intended to ensure that clinical trial subjects are not p...
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    Bringing Structure to Substance Information

    This article discusses compliance challenges pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured substance information. To support continuous pharmacovigilance oversight improvement within the EU, the European Commission has mandated pharmaceutical companies’ adherence to ISO IDMP standards by 1 July 2016 . 1 These standards collectively outline the data ...