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    FDA Formally Recognizes First Public Genetic Database

    As a way to better the development of novel diagnostics to detect and diagnose genetic diseases, the US Food and Drug Administration (FDA) on Tuesday for the first time formally recognized a public database with gene and genetic variant data. The recognized database is the Clinical Genome Resource ( ClinGen ) consortium’s ClinGen Expert Curated Human Genetic Data, which is funded by the National Institutes of Health (NIH). The database is now recognized as a source o...
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    Generic Drug Prices ‘Strongly Predictive’ of Shortages, Study Finds

    How a generic drug is priced may be the difference between whether it experiences a shortage or not, a new study published in Value in Health found. The study of commonly used outpatient generic drugs from 2008 to 2014 found that the prevalence of shortages decreased from a peak in 2011-2012 to less than 4% of the overall sample by the end of 2014. Generic drug prices “were strongly predictive of drug shortages,” the researchers found. But competition and market si...
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    Biosimilars Forum Calls for FDA Guidance to Address Misinformation

    Echoing a Pfizer petition and Novartis comments, the Biosimilars Forum said late last week that guidance from the US Food and Drug Administration (FDA) is needed to ensure reference product sponsors and other organizations communicate properly about biosimilars.   Amgen, which withdrew from the Forum recently, Roche’s Genentech and others have been singled out for misinformation campaigns that not only question the legal framework governing biosimilars but also the saf...
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    Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

    More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International Council for Harmonisation (ICH). The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, ra...
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    FDA Finalizes Guidance on Post-CRL Meetings With ANDA Applicants

    The US Food and Drug Administration (FDA) on Monday finalized guidance on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies. The 8-page guidance, first drafted in October 2017 , offers details for companies on what a post-CRL meeting request should include, how the requests will be assessed, the procedures for conducting teleconferences, the documentation of meeting...
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    How Pharmaceuticals Impact the Environment: EMA Revises Guideline

    The revision of the European Medicines Agency’s (EMA) guideline on environmental risk assessment (ERA) introduces a decision tree clarifying when ERA studies are required and provides more detailed technical guidance to help increase the consistency of the assessments. “One of the most notable changes introduced in the proposed revision is the introduction of the term ‘endocrine active substances’, to include all compounds that affect development or reproduction,” EMA e...
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    GAO Raises Questions on FDA’s Orphan Drug Designation Process

    The Government Accountability Office (GAO) announced Friday that it has found that the US Food and Drug Administration (FDA) does not always ensure that all information is consistently recorded and evaluated when making orphan drug designation determinations. The missing of these critical steps by the agency in some cases means that FDA reviewers do not fully understand the context of a drug’s intended use for the rare disease, GAO said. “The Commissioner of FDA shou...
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    EMA: Patient Registries Can Replace Clinical Trials for Certain Hemophilia MAAs

    For companies developing marketing authorization applications (MAAs) for recombinant and human plasma-derived factor VIII and factor IX hemophilia medicines in previously untreated patients (PUPs), the European Medicines Agency (EMA) announced Friday that data should be collected from patient registries rather than from small clinical trials. Revised guidance from EMA spelling out the changes notes the aim is to optimize the use of these registries and provide parameter...
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    FDA to Follow EMA With Move From London to Amsterdam

    As the US Food and Drug Administration (FDA) now communicates with its European counterparts on a daily basis, the US agency has decided to make the move from London to Amsterdam alongside the European Medicines Agency (EMA). “By maintaining an office in both Brussels and London (eventually Amsterdam), we can better leverage our resources and collaborate with our regulatory partners on higher-risk sites around the globe that sell food and medical products to both Europe...
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    FDA Warns of Rare but Serious Risks Linked to MS Drug Alemtuzumab

    The US Food and Drug Administration (FDA) on Thursday warned that serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Sanofi’s Lemtrada (alemtuzumab). In the nearly five years since FDA approved Lemtrada to treat relapsing forms of MS, the agency said it identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred short...
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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 21 November 2018 to include: Novo Nordisk said it might use its acquired PRV to...
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    Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

    The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can now rely on the inspections in each of those countries, reducing the need for duplicative work.   A total of 19 member states in the EU are now qualified by FDA as having the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. However,...