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    European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Updates Biosimilar Guidance to Allow Comparators of US Origin The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in biosimilar clinical trials. Swissmedic is now allowing biosimilar developers to use comparators sourced from the United States. That marks a change in the policy Swissmedic established whe...
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    FDA Releases Draft Guidance on Injectable Drug Dose Labeling

    Citing safety concerns, the US Food and Drug Administration (FDA) is updating its guidance to industry on how to properly label injectable drugs for their appropriate doses. The guidance also updates the agency's definition of single- and multiple-dose containers and retires the term "single-use," in favor of the term "single-patient-use," which the agency says will reduce confusion for some products. Single-Patient-Use The introduction of this new term, "single-patien...
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    FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

    • 22 May 2015
    The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week. The announcement, contained in the latest edition of the US Unified Agenda , contains 33 proposed and final rules FDA says it hopes to publish by the end of calendar year 2015. In practice, however, some rules have remained on FDA's Unified Agenda for years. FDA's latest update of the Unified contains two additional regulations compared to its las...
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    EMA Drafts New Clinical Development Guideline for Fixed Dose Combination Drugs

    In response to a rise in the use of fixed dose combination (FDC) drugs, the European Medicines Agency (EMA) has revised its guideline addressing the clinical development requirements for FDCs. Background FDCs—or drugs containing multiple active ingredients—are used to treat a variety of medical issues, ranging from the common cold to tuberculosis and HIV. For many treatments, combining multiple active ingredients can result in a simpler, more effective treatment regime...
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    In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help

    The European Medicines Agency (EMA) is looking for feedback on a new set of principles for setting the defined daily dose (DDDA) and defined course dose (DCDA) for antimicrobial products used in animals. The guideline was drafted by the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) committee, and is intended to establish standards for setting DDDA and DCDA amounts for veterinary antimicrobial products. The consultation is part of an ongoing...
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    Australian Regulator Says Smoking Device too Similar to Inhaler

    The Therapeutic Goods Administration (TGA) this week issued a safety advisory over two smoking devices that bear strong resemblance to metered dose inhalers used to treat asthma and other medical conditions. TGA says the devices, known as the Puffit and Puffix-X, are designed to “burn vegetable material such as herbs or tobacco,” which is then inhaled as smoke. TGA’s Warning The agency fears that the products’ similarity to metered dose inhalers could create con...
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    When is a Drug a 'New' Drug? Legislation Seeks to Change Definition

    New legislation introduced in the US House of Representatives last week seeks to incentivize the development of new combination drugs by redefining what a "new" drug really is. Background Under existing rules administered by the US Food and Drug Administration (FDA), not all new drug products are treated the same. New chemical entities (NCEs) that have never before been approved in the US for any indication are eligible for five years of marketing exclusivity, during wh...
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    New Fixed-Dose Combination Drugs Now Eligible for 5 Years of Exclusivity, FDA Says

    The US Food and Drug Administration (FDA) has finalized a new policy which will for the first time allow new fixed-dose combination  (FDC) drugs consisting of at least one new drug product to be eligible for five years of so-called "New Chemical Entity" (NCE) exclusivity. But in a setback for companies with existing FDCs, the agency will not apply the policy retroactively. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from...
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    Second Major Sleep Drug Associated With Impaired Driving as FDA Dials Back Recommended Dosing

    The US Food and Drug Administration (FDA) has again issued a warning about a sleep drug, this time requiring a labeling change for the popular sleep drug Lunesta after data indicated that some patients experienced long-lasting effects that could impair their ability to function, even after a full night's sleep. Background Sleep drugs have long been on FDA's radar, primarily due to their association with impaired driving. The concern has been that some patients respond a...