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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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    FDA Works to Reduce Dog Testing in Drug Development

    US Food and Drug Administration (FDA) researchers are working to develop a new informatics model to reduce the reliance on dogs to conduct studies in animal drug development.   The agency’s new study, which was proposed on Friday, is intended to aid animal drug developers in conducting certain research without the need for product testing on dogs.   Animal drug developers would be able to use the new model as a mechanism for comparing blood levels of certain oral...
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    Gottlieb, Woodcock Highlight FDA’s Efforts to Tackle Drug Shortages

    The US Food and Drug Administration (FDA) is working to update its approach to drug shortages in the wake of Hurricane Maria in 2017 and other high profile manufacturing-related shortages that occurred over the last year.   In a blog post Monday, FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock described some of the challenges facing the agency and its plans for addressing those challenges ahead of a public meetin...
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    FDA Proposes New Framework on Prescription Drug-Related Software

    The US Food and Drug Administration (FDA) issued a request for comment on Monday that sets forth a proposal for a new framework on the regulation of software applications for use with one or more prescription drug products.   The agency’s newly adopted digital health approaches “are still in their early stages,” FDA Commissioner Scott Gottlieb said Monday in remarks at the Reagan Udall Foundation annual public meeting. “A lot of these technologies haven’t advanced as...
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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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    Draft Brexit Agreement Moves Forward on Shaky Ground

    EU and UK negotiators on Wednesday advanced a draft agreement setting terms for the UK’s withdrawal from the EU in March 2019 and the two parties’ relationship during a 21-month transition period.   The agreement is being sent to the EU27 member states for consideration and must clear the UK Parliament before the negotiations can move to the next phase and avoid the possibility of a “No-Deal” scenario.   However, the deal appears to be in jeopardy after Brexit secr...
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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...