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    FDA Continues Steady Reduction of Generic Drug Application Backlog

    As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs). The new data (up to 1 July 2016) reveals that FDA has reduced its ANDA workload by about 500 applications in the first six months of 2016 (the ANDA dashboard recapping 2...
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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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    FDA Withdraws NDA for Fertility Drug After EMD Serono Fails to Run Postmarket Trial

    More than 10 years since the US Food and Drug Administration (FDA) offered accelerated approval to EMD Serono’s fertility drug Luveris (lutropin alpha for injection), the agency on Monday announced it’s withdrawing the drug’s approval as the company failed to run a postmarketing study required as a condition of approval. First approved on 8 October 2004, Luveris was indicated for concomitant administration with one of EMD Serono’s other fertility treatments, Gonal-F (fol...
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    FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling

    The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product. At the outset of the 15-page guidance, FDA makes clear that biosimilar product labeling should not include a description of a clinical study that merely supports a demons...
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    FDA Review Times Steadily Decreasing, Report Finds

    Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group. Back in 2009, FDA was averaging 21 months for reviewing new molecular and biologic entities, but five years later, that average has been cut by more than half to nine months in 2014. In addition, the number of applicants waiting more than two year...
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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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    CDC, NIH 'Working Closely' With FDA on Zika Response

    At a Congressional hearing in Washington, DC on Wednesday, officials from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) say they are working closely with the US Food and Drug Administration (FDA) in their response to the Zika virus. During the hearing, CDC Director Tom Frieden and Anthony Fauci, director of the National Institutes of Allergy and Infectious Disease (NIAID) briefed members of the House Foreign Affairs Committe...
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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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    FDA and EMA Share Perspectives on Evaluating Ebola Treatments

    Officials from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have shared their perspectives on evaluating treatments for Ebola in two articles appearing in Clinical Trials . The articles discuss some of the challenges the Ebola outbreak presented for studying drugs and vaccines to treat the disease. At the time the outbreak began, no products existed to treat Ebola, and those that were in development had not been tested in humans. Study ...
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    Cruz Calls for Major Overhaul of FDA

    Republican presidential candidate Sen. Ted Cruz (TX) and Sen. Mike Lee (R-Utah) on Friday introduced a bill that would completely overhaul the way the US Food and Drug Administration (FDA) operates. More specifically, the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388), or the RESULT Act,” would: allow for reciprocal approval of drugs, devices and biologics from foreign sponsors in EU member countries, Israel, Australia, Canada and Japan r...
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    New Law Redefines When Controlled Substances are Officially Approved

    Just before the Thanksgiving holiday weekend, President Barack Obama signed a new law that will effectively provide the pharmaceutical industry with more certainty on when controlled substances are officially approved. The new law, known as the Improving Regulatory Transparency for New Medical Therapies Act, sets new deadlines for the US Drug Enforcement Administration (DEA) to schedule controlled substances, like opioids and other drugs that have the potential to be abu...
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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...