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    Generic Drug Approvals Hit New Record in 2015, FDA Report Shows

    • 13 April 2016
    The US Food and Drug Administration (FDA) approved more generic drugs in 2015 than ever before and is on track to meet all of its goals from the Generic Drug User Fee Act of 2012 (GDUFA) by 2017, according to the first annual report from FDA’s Office of Generic Drugs (OGD). More than 700 generic drugs were approved and tentatively approved in 2015, which was the highest figure ever; and in December, FDA granted the highest number of approvals and tentative approvals in...
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    WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries

    A World Health Organization (WHO) pilot project looking to bring already-approved drugs to Africa more quickly will continue into 2016 after four of 11 participating African national medicines regulatory authorities (NMRAs) approved Janssen’s pediatric HIV drug Intellence (etravirine). As of November, regulators from Namibia (approved 86 days after submission), Cote d’Ivoire (four months), Botswana (six months) and Kenya (seven months) have approved the use of the drug, ...
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    FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II

    Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017. Since 2012, when the first GDUFA was created to provide FDA with indu...
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    First-in-Class, Rare Disease Drug Approvals Dominated in 2015: A Breakdown from FDA

    Last year was a banner year for the US Food and Drug Administration (FDA) in terms of new drug approvals, with many of the new drugs coming to market to help rare disease patients and offer new first-in-class options. The total of 45 approvals was well ahead of FDA’s average of about 28 novel approvals between 2006 and 2014, and 36% of those new approvals were for first-in-class drugs while almost half (47%) were to treat rare diseases, or ailments that impact 200,000 or...
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    EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record

    In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014 , granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17. Notably, EMA trailed just behind the US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) for the year. In 2015, CDER approved 45 new drugs, 21 of which had been granted orphan drug designati...
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    Five Years of Cancer Drug Approvals: Most Cost Too Much and Give Us Too Little

    This is the guest post rebuttal (to this post from Mark Shapiro, VP of Clinipace) by Dr. Vinay Prasad, Assistant Professor of Medicine in the Division of Hematology Oncology in the Knight Cancer Institute. Prasad also  holds appointments in the Department of Public Health and Preventive Medicine, and as Senior Scholar in the Center for Health Care Ethics at Oregon Health & Science University. Mr. Shapiro comments on some of the arguments made in our investigation o...
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    House Panel Calls on GAO to Study FDA’s Approval Pathway for Complex Generics

    Chairman of the House Committee on Energy & Commerce Fred Upton (R-MI), ranking member Frank Pallone (D-NJ) and other representatives on both sides of the aisle are calling on the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) approval pathway for generic drugs that have complex active pharmaceutical ingredients (APIs). The request for GAO action follows the introduction of HR 1576 in March, which also calls on GAO to study...
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    CDER’s Woodcock Outlines Priorities for 2016

    With a banner year for new drug approvals under its belt in 2015 (42 approvals and counting), the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is now looking at how it can not only negotiate three new user fee agreements but fill an enormous number of staff vacancies. CDER Director Janet Woodcock, speaking Monday at the FDA/CMS Summit in Washington, DC, outlined 2015’s achievements and a number of the agency’s top priorities for ...
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    Researchers Question Consistency of FDA’s Use of Surrogate Endpoints for Drug Approvals

    The US Food and Drug Administration (FDA) is not consistent with its use of surrogate endpoints in assessing the risks and benefits of treatments for some diseases, making it difficult to assess the treatments' actual clinical effects on outcomes important to patients, according to researchers from Johns Hopkins. The researchers came to this conclusion after evaluating 58 FDA drugs approved between 2003 and 2012 for chronic obstructive pulmonary disease (COPD), Type 1 an...
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    FDA Sees Record-High PMA Approval Rate for 2015

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015 and the spike may be linked to FDA’s improved assessment of PMA deficiencies earlier in the review process. The 98% approval rating in 2015 for PMAs is the highest FDA has seen in at least 15 years, and 8% higher than the next highest from 2005, according to a 371-page quarterl...
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    US Special Counsel Finds FDA Whistleblower's Device Approval Concerns Unsubstantiated

    The claims of an anonymous whistleblower within the US Food and Drug Administration (FDA) that employees of the Center for Devices and Radiological Health (CDRH) created public health dangers by approving the use of a digital mammography device and several colonography devices were found to be unsubstantiated, according to a letter sent by the US Office of Special Counsel (OSC) to President Barack Obama. Background Six staff scientists, former employees of CDRH's Office...
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    OpenFDA Releases Huge Trove of Medical Device Data

    On Monday, the US Food and Drug Administration (FDA) released a vast amount of medical device data to its openFDA platform. Background The openFDA initiative was originally born from an order from the White House , which called for federal agencies to implement a new " digital strategy " to make government information more accessible to the public. The strategy focused on creating APIs – not active pharmaceutical ingredients, but application program interfaces – that ...