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    MHRA to Classify Some GCPs as Medicines

    After reviewing the level at which glucosamine containing products (GCPs) have a pharmacological effect on the body and evaluating why people use GCPs, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) intends to regard GCPs, with a level of base glucosamine equal to or greater than 1178mg/day, as medicines. The decision follows a Court of Appeal Judgment in 2016 which began the review of the classification of GCPs, which are widely available as supple...
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    Revolving Door Between Industry and FDA Continues to Spin

    It’s well known that leaving the US Food and Drug Administration (FDA) for industry can bring a major salary bump, so it should come as no surprise that the number of FDA employees making the leap in 2018 continues to increase. Biotech company Moderna announced Wednesday that Wellington Sun, former director of the Division of Vaccines and Related Product Applications at FDA’s Center for Biologics Evaluation and Research, will be their new head of vaccine strategy and ...
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    FDA Developing ICH Reflection Paper on Generic Drugs

    An informal working group at the US Food and Drug Administration (FDA) is developing a reflection paper outlining an approach for developing and enhancing ICH guidelines to support the harmonization of scientific and technical standards for generic drugs, Theresa Mullin, associate director for strategic initiatives at FDA, told attendees of the Association for Accessible Medicines conference on Wednesday. The proposed work, according to Mullin, would target scientific a...
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    FDA Reveals How Manufacturing Facilities are Prioritized for Inspections

    The US Food and Drug Administration (FDA) on Wednesday released an internal Manual of Policies and Procedures (MAPP) on how pharmaceutical manufacturing sites are prioritized and selected for surveillance inspections. The release of the 7-page MAPP comes as FDA’s inspections program in Fiscal Year 2017 had to decide what sites to inspect from about 5,063 human pharmaceutical sites worldwide, 3,025 of which are outside the US. In 2017, FDA conducted 1,453 inspections, in...
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    Nonallergic and Allergic Rhinitis: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized two guidance documents: one on developing treatments for nonallergic rhinitis (NAR) and one on developing allergic rhinitis treatments. The guidance to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults, finalizing a draft from February 2016, addresses issues of trial design, effectiveness and safety for new products being developed for the tre...
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    Generic Drugmakers Embrace Inter Partes Review Process

    Thanks to Congress’ administrative alternative to court litigation of patents, generic drug manufacturers have embraced a new process, known as inter partes review (IPR), and successfully challenged patents about 50% of the time, according to a new study published in Applied Health Economics and Health Policy . The study, written by researchers at the Program On Regulation, Therapeutics, And Law (PORTAL) at Harvard Medical School and Brigham & Women’s Hospital, reveals...
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    Companies Discuss Biosimilars, Suggest Reforms at FDA Public Meeting

    Advocates for biosimilars and their reference products came together Tuesday at the US Food and Drug Administration (FDA) to discuss various ways to better facilitate competition in the biologics marketplace. Many of the speakers discussed ways in which the Purple Book should be reformed, particularly with new additions to make it a more useful resource, while others pushed for ways to increase biosimilar uptake and transparency. Kicking off the meeting, Andrew Green...
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    Sanofi Pays $25M to Resolve Corrupt Payments in Middle East

    The Securities and Exchange Commission (SEC) on Tuesday announced that Paris-based pharmaceutical company Sanofi has agreed to pay more than $25 million to resolve charges that its Kazakhstan and Middle East subsidiaries paid foreign officials and health care professionals to improperly influence and increase sales of Sanofi products. In Kazakhstan, distributors were used as part of a kickback scheme to generate funds from which bribes were paid to officials to ensure t...
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    Pfizer Calls for FDA Guidance to Address False and Misleading Biosimilar Ads

    Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, Pfizer is asking the US Food and Drug Administration (FDA) to take action with new guidance on what’s acceptable. In a citizen petition filed Monday, Pfizer notes examples of what it calls “inappropriate communications” and “misleading representations and suggestions by reference product sponsors.” The issue at hand isn’t so much that the info...
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    Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal

    As part of a preliminary trade deal between the US and Mexico, to update the 24-year-old North American Free Trade Agreement (NAFTA), both sides agreed to 10 years of data protection for biologics and expanded scope of products eligible for protection. But generic drugmakers came out against that deal on Tuesday, as it would be longer than what both Mexico and Canada currently have – Mexico currently enjoys a period of five years of data exclusivity for biologics while ...
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    FDA Warns 21 Websites Marketing Unapproved Opioids

    The US Food and Drug Administration (FDA) on Tuesday took action to stem the spread of opioids online. The agency warned four online networks operating 21 websites illegally marketing unapproved and misbranded versions of opioids, including tramadol. “The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis. Cutting off this flow of illicit internet traffic in opioids is critical, and we’ll continue to pursue ...
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    Updated: FDA Warns Zimmer Biomet’s Indiana Plant

    Zimmer Biomet announced Friday via an SEC filing that it received a warning letter related to observed non-conformities with current good manufacturing practice (CGMP) requirements of the quality system regulation at its manufacturing facility in Warsaw, Indiana. The warning letter follows a lengthy Form 483 for the facility in May and another 483 dating back to 2016 , though the company said it believes that FDA’s concerns “can be resolved without a material impact...