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    EMA Warns of Impurity in Valsartan From Mylan

    The European Medicines Agency (EMA) on Monday announced the European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended the certificate of suitability to the monographs of the European Pharmacopeia (CEP) for Mylan Laboratories in Hyderabad, India. The action follows the identification of an impurity, N-nitrosodiethylamine (NDEA), in some batches of valsartan made by Mylan. The finding is just the latest in a series of NDEA and N-nitrosodimethyl...
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    EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

    Though the European Medicines Agency (EMA) and Canada have had a mutual recognition agreement (MRA) in operation since February 2003, both sides announced Monday that they may further strengthen their ties. On Friday, the European Commission’s DG Sante, EMA and Health Canada held the first Joint Sectoral Group (JSG) on Pharmaceuticals, which is a specialized committee established under the Committee on Trade in Goods of the Comprehensive Economic and Trade Agreement (CE...
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    AdvaMed and AAMI Weigh FDA Draft Guidance on Voluntary Consensus Standards

    Medical device industry group AdvaMed and the Association for the Advancement of Medical Instrumentation (AAMI) are seeking additional information from the US Food and Drug Administration (FDA) on draft guidance related to the recognition and withdrawal of voluntary consensus standards. The 8-page draft from September describes the procedures that FDA follows and the actions the agency may take during its review and evaluation of requests for standards recognition or ...
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    Majority of Open PMRs and PMCs Progressing on Schedule, FDA Report Shows

    The majority of the open postmarket requirements (PMRs) and commitments (PMCs) in the US Food and Drug Administration’s (FDA) database continues to progress on schedule, according to data from the latest report released Friday. Background A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct following approval, while a PMC is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that ...
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    EMA Recommends First All-Oral Treatment for Sleeping Sickness

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it has adopted a positive scientific opinion of Fexinidazole Winthrop (fexinidazole), the first oral-only medicine for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness.   This approval is a result of clinical trials led by the non-profit research and development organization DNDi, with an application submitted to EMA b...
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    PMA Denials: Why so Few?

    In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified that the company has received such a letter. But in the world of medical devices, failing to win approval for a high-risk device is a much more closely held secret, and companies can withdraw their applications rather than be denied approval.   A Federal Register notice ...
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    Novartis Calls for FDA Enforcement Against Biosimilar Misinformation

    Building off a Pfizer citizen petition on biosimilar misinformation, Novartis is calling on FDA to set the record straight on what information can be disseminated. The misinformation campaigns, as explained in Pfizer’s petition from August, “further demonstrate efforts to foster fear and highlight hypothetical yet unproven risks associated with the use of FDA-approved biosimilars,” Novartis said. Amgen, Genentech and others are called out for these campaigns that n...
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    Water Quality for Pharmaceutical Use: EMA Opens Consultation

    With the aim of replacing guidance from 2002 on quality of water for pharmaceutical use, the European Medicines Agency (EMA) is offering new draft guidance for industry on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use. EMA says the guidance should be considered for those submitting new marketing authorization applications (MAAs), as well as any variant applications to exist...
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    Pazdur, Marks and Woodcock Discuss FDA Changes, What’s Coming

    Three of the US Food and Drug Administration’s (FDA) directors – Richard Pazdur, Peter Marks and Janet Woodcock – took the stage Wednesday at Prevision Policy’s Biopharma Congress to discuss all things FDA – from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers. Center for Drug Evaluation and Research Director Woodcock said that the difference between years past, when FDA was viewed negatively, and now is tha...
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    Woodcock Pushes for Major Digital Shift in Regulation

    Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, made clear on Tuesday that there needs to be a major shift in regulatory toward a more digital world. “The time has come that we think about digital tech in a new way to streamline and use the digital age to effectively regulate and efficiently regulate,” Woodcock said at the Friends of Cancer Research annual meeting Tuesday. She noted that regulators arou...
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    FDA Begins Updating Generic Chemotherapy Labels

    As part of efforts to ensure older generic drug labels remain relevant, the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) has begun updating generic chemotherapy labels. Speaking at Friends of Cancer Research’s annual meeting on Tuesday, FDA Office of Hematology and Oncology Products (OHOP) Supervisory Associate Director Amy McKee explained the push to update the labels, known as Project Renewal, which will update about 40 generic chemother...
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    Review Addresses Obstacles to US Biosimilar Entry and Uptake

    Although 14 biosimilars have now been approved by the US Food and Drug Administration (FDA), only six have reached the market and questions about the viability of the biosimilar industry in the US have been raised. According to a review published by Ameet Sarpatwari and others from the Department of Medicine at Brigham and Women's Hospital and Harvard Medical School in Clinical Pharmacology & Therapeutics , there are several steps FDA and lawmakers can take to ensure t...