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    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
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    China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

    Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...
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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...
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    Too Fast, or Too Slow? Public Disagrees Over Pace of FDA's New Drug Approvals

    According to a new survey, the US Food and Drug Administration (FDA) is in a lose-lose situation when it comes to regulating healthcare products. FDA's Lose-Lose Proposition The poll, sponsored by research advocacy group Research!America and conducted with help from Zogby Analytics, polled approximately 1,000 adults about their views on America's role in public health research and development. The research indicates, for example, that Americans are broadly in favor of ...
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    Report: FDA Drug, Device Approval Times Improving

    A new report issued by the consulting group PricewaterhouseCooper (PWC) indicates that the US Food and Drug Administration (FDA) is making sustained improvements to its drug and medical device approval processes, resulting in new products reaching consumers more quickly. PWC's report, The FDA and industry: A recipe for collaborating in the New Health Economy , is a wide-ranging look at FDA's performance and industry's assessment of its interactions with the regulator....
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    Among Global Drug Regulators, FDA Still the Best, But Others Are Catching up—Fast

    Six of the world's most preeminent regulatory bodies have become increasingly adept at approving new drug products more quickly and consistently, according to a new analysis published by the Centre for Innovation in Regulatory Science (CIRS). Background: Study CIRS' analysis looked at new drug approval decisions made over the past decade by six regulators: The US Food and Drug Administration (FDA) The European Medicines Agency (EMA) Japan's Pharmaceutical and Medica...
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    FDA Touts Strong Drug Approval Performance in 2014

    The US Food and Drug Administration (FDA) is touting the number of new molecular entities it has approved thus far in 2014, saying the numbers are indicative of a "strong year for novel drug approvals." A Strong Year for Approvals "With a few weeks left in December, our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel new drugs in 2014 compared to 27 in 2013," said FDA Commissioner Margaret Hamburg in a posting on the agency's FDA Voice blo...
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    How Many Drug Companies Manage to Get Two New Drugs Approved by FDA? Not Many

    The development of a new pharmaceutical or biopharmaceutical product is a notoriously difficult process. According to industry data compiled by the Tufts Center for the Study of Drug Development, only about one in 10 drugs entering into Phase I clinical trials will ever be approved by the US Food and Drug Administration (FDA)—and those are just the companies whose drugs actually made it to the clinical development stage.  Getting a drug approved, in other words, can feel ...
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    Report Finds FDA Slow to Approve CNS Drugs, But Getting Faster

    A new report published by the Tufts Center for the Study of Drug Development (CSDD) validates longstanding data indicating that drugs intended to treat disorders of Central Nervous System (CNS) take longer to develop and are rejected by US Food and Drug Administration (FDA) regulators at a higher rate than are other drugs. Background Disorders of the central nervous system are as diverse as they are challenging to treat. Some of the most common CNS disorders include dep...
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    FDA Approving New High-Risk Devices at Fastest Pace in Last Decade, Report Finds

    A new analysis by the California Healthcare Institute (CHI) indicates that after years of unprecedentedly high review times, the US Food and Drug Administration is finally beginning to accelerate the pace at which it reviews innovative high-risk medical devices. Background The data, contained in CHI's report, Taking the Pulse of Medical Device Regulation and Innovation , found broad improvement at FDA's Center for Devices and Radiological Health (CDRH), which...
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    How Many Drugs has FDA Approved in its Entire History? New Paper Explains

    Pop quiz: While the US Food and Drug Administration (FDA) approves dozens of drugs each year, how many new drugs—i.e. discounting generic versions of approved drugs—has it approved in its entire existence? Until recently, the answer to that question wasn't easy to find. You couldn't find the answer on FDA's website, and even digging into FDA's so-called "Orange Book," which contains a list of all approved drugs and their generic equivalents, wouldn't give you a complete ...
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    FDA Device Approvals Speedy in First Half of 2014, With Even Faster Approvals Coming Soon

    The US Food and Drug Administration (FDA) approved new medical device products at a pace nearly twice that of the year prior, according to a new report just published by analysts at EP Vantage, the market intelligence branch of Evaluate. New Report EP Vantage's half-year report looked at all medical devices approved by FDA through its Premarket Approval (PMA) pathway and its Humanitarian Device Exemption (HDE) pathway —both used almost exclusively by entirely new devic...