• Regulatory NewsRegulatory News

    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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    Asia Regulatory Roundup: China Looks to Revamp Drug Approval Process (3 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Proposes Drug Approval Reforms to Encourage Innovation Senior Chinese officials are considering adopting legislation that would overhaul the drug evaluation and approval process in the country to encourage innovation by incentivizing research. As it stands, only manufacturers can apply for drug approvals in China. Officials are now considering whether this disincen...
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    Are the Days of FDA Approving 'Basically Everything' Falling by the Wayside?

    In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week. FDA's drug review process has long been recognized as the gold standard globally (FDA even mentioned that gold standard moniker in congressional testimony ) and as recently as 2008, ...
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    FDA Offers New Insight on When to Submit PMA Supplements for Device Manufacturer Site Changes

    Medical device companies trying to understand what officially constitutes a manufacturing site change and when to submit a premarket approval (PMA) supplement will want to consult with draft guidance from the US Food and Drug Administration (FDA) released Tuesday. According to FDA, the agency has received a number of questions on various scenarios that might require a device manufacturer to use a different site for manufacturing, processing or packaging a device. In...
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    Senate Committee Advances Bill Redefining When a Drug is Officially Approved

    A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday. Background In order for a drug to be marketed, it must not only be approved by the US Food and Drug Administration (FDA), but the US Drug Enforcement Agency (DEA) must also schedule the drug to a particular class under the Controlled Substances Act (CSA). Under current law...
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    Studies Raise New Concerns Over FDA's Expedited Approval Designations, Supplemental Indications

    An increasing number of newly-approved drugs by the US Food and Drug Administration (FDA) have been associated with expedited development or review programs, though many of these approved drugs are not first in class and potentially less innovative, according to two new studies published in the British Medical Journal (BMJ). Background Under the standard regulatory review process, FDA has 10 months to review a potential new drug's safety and efficacy based on a company'...
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    FDA Isn't Waiting Around for 'Cures' to Speed Access to Devices

    While the Congress is busy working on the 21st Century Cures Act , which is expected to speed access to new drugs and devices, a new report from EP Vantage shows FDA isn't sitting on its hands. 2015: A Record Year for Device Approvals? In the first half of 2015, FDA has already cleared 26 devices with either premarket approval (PMA) or a humanitarian device exemption (HDE). To put that in perspective, in half a year FDA has already granted more PMAs and HDEs to new ...
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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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    FDA Explains how Companies can Modify a Drug Safety Assurance Plan

    A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs. Background The policies, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007 Food and Drug Administration Amendments Act (FDAAA) and are meant to ensure the safe use of potentially risk...
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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...
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    Melanoma Treatments: A History of US FDA Approvals

    Studying the history of regulatory approvals can provide insights into regulator expectations for new products. The authors undertook an investigation to examine the data sets on which previous US Food and Drug Administration (FDA) approvals for melanoma treatment products were based to determine whether trends have changed in the level of evidence provided. Melanoma was chosen due to its relevance to ongoing projects by the authors. Methodology The authors obtai...