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    Global Regulatory Strategy

    This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers. The term "strategy," per Merriam Webster (Edition 11), means "a careful plan or method for achi...
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    FDA Establishes New Process for Preliminary Combination Product Classification

    Top officials at the US Food and Drug Administration (FDA) say the agency is developing a new, less formal, way for industry to request input on how combination products will be regulated. Combination Products Combination products are products that combine two or more different types of FDA-regulated products, including drugs, biologics and medical devices. However, when it comes to reviewing such products, FDA makes a determination as to how the product will be classif...
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    CDRH Offers Peek Inside New Expedited Access Program for Breakthrough Devices

    A little more than a year since the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) put the finishing touches on a new expedited review process for potentially life-saving medical devices and the agency has accepted almost 60% of the applications of those looking to be a part of the new program. Over the past year, CDRH has made 29 decisions on requests for designation into its voluntary Expedited Access Pathway (EAP) program, an...
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    Physicians Lack Understanding of What ‘Breakthrough’ Designation Means, Study Finds

    A US survey of board-certified internists and specialists revealed “substantial deficits in knowledge” of what it means for a drug to be approved by the US Food and Drug Administration (FDA) and approved via the “breakthrough” pathway, according to a research letter published in JAMA on Tuesday. Since 2012, FDA has designated certain drugs as "breakthrough” therapies (76 drugs have received the designation through April 2015) if preliminary clinical evidence – such as ...
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    Analysis: Breakthrough Therapies Cut Development Timeline by Two Years

    A nonprofit cancer advocacy group says that the US Food and Drug Administration's (FDA) breakthrough therapy designation has been effective in shortening the amount of time it takes to develop new oncology drugs by more than two years. In a paper published in The Pharmacogenomics Journal in March, the authors from the Friends of Cancer Research say that cancer drugs with breakthrough therapy designations also see faster approval times than non-breakthrough products as ...
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    Report: Competition Quickly Follows First-In-Class Approvals

    By the time "first-in-class" drugs receive marketing approval in the US, nearly all later iterations of those products have begun clinical testing or filed a new drug application with the US Food and Drug Administration (FDA), according to a new study by Tufts Center for the Study of Drug Development. The study, which compared 40 drug classes with a first-in-class approval between 1998 and 2011, found that the race for marketing approval for new classes of drugs and biol...
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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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    What Causes Variations in Review at CDER? It's All About the Designation

    Last year, a study by the Manhattan Institute for Policy Research (MIPR) found variations in review time at the US Food and Drug Administration's (FDA) various drug review divisions were caused by inefficiencies at the agency. Now, FDA representatives are making the case that the variation in review times can be explained by the proportion of applications receiving accelerated review in different therapeutic areas. The MIPR study concluded that the variations in rev...
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    EMA in 2014: A Landmark Year for Approvals, With Eyes on the Future

    In the European Medicines Agency's (EMA) Annual Report 2014 , top regulatory officials describe the agency's role as both a "gatekeeper" and "enabler." This dual role means that the agency must not only work to ensure the safety of patients in the EU, but also to facilitate the development of new and innovative therapies. By the Numbers 2014 was a landmark year for EMA in many ways. The agency recommended record numbers of products to treat rare diseases , launched it...
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    New FDA Program to Expedite the Approval of 'Breakthrough' Medical Devices

    The US Food and Drug Administration (FDA) has put the finishing touches on two policies intended to expedite access to potentially life-saving devices meant for patients with life-threatening diseases or conditions. Background FDA's Center for Devices and Radiological Health (CDRH) has for several years been putting the finishing touches on two conceptually related guidance documents: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for U...
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    Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

    In recent years, the US Food and Drug Administration (FDA) has made great advances in the review of new drugs. The US now is reported to lead the world in both timeliness and quantity of noteworthy new drug approvals. 1 This trend is due in part to FDA’s ongoing commitment to improve the drug development process and establish robust, efficient and predictable development programs. As a result, products demonstrating a positive benefit-risk profile and appropriate e...
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    FDA’s Expedited Programs for Serious Conditions: An Overview

    For some serious or life-threatening diseases, few therapeutic options exist. Once a promising therapy is discovered, establishing its clinical benefit and safety profile is necessary but can be time consuming. Standard drug development programs involve formulating and manufacturing the drug product, characterizing the new drug, gathering adequate evidence on its performance, evaluating the safety risks and confirming the effects observed in the early clinical trial...