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    Child Resistant Packaging: FDA Finalizes Guidance on Labeling Statements

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on child-resistant packaging (CRP) statements that should be included in the labeling of prescription and over-the-counter (OTC) drugs.   The seven-page final guidance comes two years after FDA released the draft version for comment. FDA says it considered the comments submitted to the public docket and has edited the guidance for clarity.   Under US Consumer Product Safety Commission (CPSC) ...
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    NDEA and NDMA Impurities: Another Indian Manufacturer Receives an FDA Warning Letter

    The fallout from the N-Nitrosodiethylamine (NDEA) and N-Nitrosodimethylamine (NDMA) impurities fiasco continues as the US Food and Drug Administration (FDA) last week sent a warning letter to India-based Lantech Pharmaceuticals. Lantech, which was placed on import alert in June and acts as a contract solvent recovery facility for valsartan active pharmaceutical ingredient (API) manufacturers, failed to perform an adequate investigation into a customer’s contaminated v...
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    Gastroparesis: FDA Revises Draft Guidance

    The US Food and Drug Administration (FDA) on Tuesday updated draft guidance from July 2015 to address public comments and reflect the agency’s current thinking on the development of clinical outcome assessment measures and statistical considerations to assess primary and secondary efficacy endpoints of clinical trials for gastroparesis. The nine-page draft explains: “Until a well-defined and reliable PRO [patient-reported outcome] instrument that measures all the clinic...
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    New Research Questions FDA’s Reliance on and Inability to Enforce Postmarketing Requirements

    As the US Food and Drug Administration (FDA) has increasingly relied on postmarketing requirements (PMRs) to support its approval decisions, a new study published in the Milbank Quarterly discusses how FDA’s lack of ability to enforce PMRs reveals an agency “on guard against a set of larger political threats to its mandate.” The study’s publication follows a recent report from FDA showing that most of the required PMRs and voluntary postmarketing commitments (PMCs) ...
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    Amgen Wins Enbrel Patent Suit Preventing Sandoz Biosimilar Launch

    A US District Court Judge in New Jersey on Friday upheld the validity of two of Amgen’s patents for its blockbuster arthritis treatment Enbrel (etanercept), preventing the launch of a biosimilar developed by Novartis’ Sandoz division.   So far, the US Food and Drug Administration (FDA) has approved two Enbrel biosimilars, Sandoz’ Erelzi (etanercept-szzs) in August 2016 and Samsung Bioepis’ Eticovo (etanercept-ykro) last April, but neither have launched commercially...
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    Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity

    Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say.   The public comment period on FDA’s draft guidance closed with 90 submissions, including from PhRMA, Roche/Genentech, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), the National Center for Health Research (NCHR), the Amer...
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    Daiichi-Sankyo, Bayer, Otsuka and Others Called Out for UK Advertisement Breaches

    The UK’s Prescription Medicines Code of Practice Authority (PMCPA) this month and next month will publish ads in the British Medical Journal , the Pharmaceutical Journal and the Nursing Standard to highlight misleading advertisements and promotional materials made by companies Daiichi-Sankyo, GW Pharmaceuticals, Bayer, Otsuka and Proveca. In the case of Daiichi-Sankyo, the company issued a corrective statement for distributing two information guides on Lixiana (e...
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    Grassley Calls for More Unannounced Foreign Drug Inspections From FDA

    As the US Food and Drug Administration (FDA) explores plans to lower the cost of pharmaceuticals with imports from Canada and elsewhere, Sen. Chuck Grassley (R-IA) is calling on the agency to perform more unannounced inspections of foreign facilities. Thanks to recent media coverage (on  China and tainted blood pressure medicines  and another article on  generic drug manufacturing ) as well as a controversial new book on the US reliance on foreign-made generic medicin...
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    Questions Pile up for Novartis as Senators Call on FDA to Take Action

    Why wait three months to tell the US Food and Drug Administration (FDA) about manipulated data? Why wait two months between documenting an initial issue and opening a nonconformance report (NCR)? And how harshly will FDA act? These questions and more are piling up for Novartis, following last week’s announcement that FDA is investigating the company for manipulating data linked to its $2.1 million gene therapy Zolgensma (onasemnogene abeparvovec-xioi). In Europe, regu...
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    Canada Finalizes Amendments to Drug Pricing Regulations

    The government of Canada announced Friday final amendments to drug-pricing regulations that aim to better protect Canadians from patented drugs’ excessive prices with new regulatory tools.   The final amendments to Canada’s Patented Medicines Regulations crack down on excessive prices by building on the federal drug price regulator’s controls to make patented drugs more affordable. The move will have a ripple effect across other countries and has already been met wit...
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    FDA Solicits Industry Input for OND Policy Priorities

    A Friday US Food and Drug Administration (FDA) notice is soliciting policy suggestions from industry that review staff at FDA’s Office of New Drugs (OND) can implement in the near future.   To hear from industry on “specific, actionable policy suggestions that could be implemented in the near-term,” FDA is soliciting presentations for discussions at a public meeting set via the Federal Register notice as well as inviting comments on the topics that the notice discuss...
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    IMDRF Drafts Requirements for Recognition of Conformity Assessment Bodies

    The International Medical Device Regulators Forum (IMDRF) opened a consultation on a draft document that sets forth requirements for regulatory authorities’ recognition of conformity assessment bodies (CABs).   The draft document proposes general and specific requirements as well as structural, resource, procedural, management system and information requirements for a regulatory authorities’ recognition of CABs for medical devices. It also outlines a process for author...