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    FDA, DOJ Investigate Galena Biopharma’s Former Promotions of Fentanyl

    Galena Biopharma on Monday disclosed in an SEC filing that the US Attorney’s Office for the District of New Jersey and the US Department of Justice (DOJ) are pursuing a criminal investigation, in addition to a previously announced civil investigation, related to the marketing and promotion of its deadly opioid Abstral (fentanyl), which the company sold for $8 million upfront in 2015. The details of the criminal investigation have not been disclosed. “There also have b...
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    FDA’s Office of New Drugs Director to Retire

    After nearly 25 years of service at the US Food and Drug Administration (FDA), John Jenkins , M.D., Director of the Office of New Drugs (OND), will retire from the federal government on 6 January 2017. For the past 15 years, Jenkins has led OND in its difficult tasks of setting US standards for new drugs’ safety and efficacy, overseeing the clinical testing of investigational drugs and reviewing marketing applications under Prescription Drug User Fee Act (PDUFA) time...
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    FTC Plans Crackdown on Marketing Claims of OTC Homeopathic Drugs

    The Federal Trade Commission (FTC) on Tuesday announced a new enforcement policy that will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims. The policy was informed by an FTC workshop held last year to examine how such drugs are marketed to consumers. The FTC also released its  staff report on the workshop , which summarizes the panel presentations and related public comments in addition to describing...
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    EMA Recommends Nine Drugs for Approval

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics. As for the new medicines, CHMP recommended granting a marketing authorization to CSL Behring’s Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with hemophilia A, Novo Nodisk’s Fiasp (...
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    FDA Report Offers Complicated Picture of Industry Compliance With Postmarket Requirements

    The majority of ongoing postmarketing requirements (PMRs) and postmarketing commitments (PMCs) from Fiscal Years 2013 and 2014 were on schedule, but a large number of companies are still struggling to meet some of these regulatory requirements on time, the US Food and Drug Administration (FDA) said in a new report issued Friday. The slew of data released by FDA offer a murky look at how drugmakers meet such postmarket requirements once a new drug or biologic is ...
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    Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (11 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes to Bring GMPs up to WHO Standard, Scrap Need to Renew Licenses The Drug Controller General of India (DCGI) is proposing to bring the country’s good manufacturing practices (GMPs) up to the standard set by the World Health Organization (WHO). DCGI Dr. GN Singh unveiled the proposal alongside plans to end the need for manufacturers, sellers and testers of ...
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    For Developers of New Genome Sequencing Analytical Tools, FDA Launches ‘App-a-Thon’

    The US Food and Drug Administration (FDA) on Monday launched what it’s calling an “App-a-Thon,” inviting software developers to get together and add next-generation sequencing (NGS) software apps to the precisionFDA app library. The challenge, which closes 28 October 2016, is looking to engage the NGS community in the development of new genome sequencing analytical tools for use on precisionFDA, which is an online research portal for NGS assay evaluation and regul...
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    European Regulatory Roundup: UK to Increase Regulatory Oversight of Antibiotics (22 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Plans Significant Increase in Regulatory Oversight of Antibiotics The United Kingdom government expects regulatory oversight of veterinary antibiotics to increase significantly in the future. Ministers singled out the enactment of legislation that restricts or bans the veterinary use of antibiotics that are of critical importance to people as one of the ...
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    Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing

    Illinois Attorney General Lisa Madigan on Thursday filed a lawsuit against Insys Therapeutics for deceptively marketing and selling its opioid Subsys (fentanyl), approved exclusively for the treatment of cancer pain, to physicians treating non-cancer patients for off-label uses like back and neck pain. Madigan alleges that Insys illegally marketed its painkiller to doctors who prescribed high volumes of opioid drugs instead of focusing its marketing on oncologists...
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    FDA Rejects Highest Number of Monthly Generic Drug Applications Ever

    The common refrain that the US Food and Drug Administration (FDA) has been approving an exorbitantly high number of drug applications for generic drugs, known as abbreviated new drug applications (ANDAs), to increase market competition in recent years is slowing down in recent months. In the latest release of raw data on Tuesday of approvals and complete response letters (CRLs), also known as rejections, for ANDAs, FDA said that in the month ending 16 April 2016, it...
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    ‘Truthful and Non-Misleading’: GOP Reps Take Issue With FDA’s Handling of Off-Label Marketing

    The tricky part about the off-label marketing of drugs, or the marketing of drugs to doctors for unapproved indications, is that companies, and not the US Food and Drug Administration (FDA), may get to decide what some courts are referring to as “truthful and non-misleading” marketing information. Republican Reps. Fred Upton (MI) and Joe Pitts (PA) on Thursday took FDA to task for the agency’s “inability or unwillingness to publicly clarify its current thinking” on off-l...
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    FDA Slowly Chips Away at ANDA Backlog

    Although the total workload of abbreviated new drug applications (ANDAs) continues to rise, the number of ANDAs currently with the US Food and Drug Administration (FDA) has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released on Monday. The latest data, covering the period from January through March 2016, shows that the number of ANDAs pending filing review has declined from 211 ANDAs as of 1 Janua...