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    FTC Takes Action Against Pharmaceutical 'Product Hopping'

    The Federal Trade Commission (FTC) on Thursday criticized the way brand-name drug manufacturers often tweak products' formulations shortly before a generic's entry to market, thereby delaying competition. The practice, commonly known as "product hopping," can end up harming consumers as it impedes competition "from would-be generic entrants, which have sought FDA approval to sell a generic version only of the original formulation but not the replacement,” FTC says in an ...
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    Bringing Structure to Substance Information

    This article discusses compliance challenges pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured substance information. To support continuous pharmacovigilance oversight improvement within the EU, the European Commission has mandated pharmaceutical companies’ adherence to ISO IDMP standards by 1 July 2016 . 1 These standards collectively outline the data ...
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    FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

    A new batch of bioequivalence recommendations issued by the US Food and Drug Administration (FDA) aims to make it easier for generic drug manufacturers to eventually make copies of several popular drugs, including Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir). Background Bioequivalence recommendations are a critical part of the submission of an Abbreviated New Drug Application (ANDA)—the application generic drug companies subm...
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    EMA Reflects on Advanced Therapy Classification

    The European Medicines Agency (EMA) has released a new reflection paper discussing how products are classified as advanced therapy medicinal products (ATMPs). Background In the EU, medicinal products derived from genes, cells or tissues are classified as ATMPs. Because these areas of biomedicine are still in early stages of development and are fundamentally different from other types of medicine, the European Commission (EC) regulates them differently. ATMPs are define...
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    EMA Releases Draft Guideline on Epidemiological Data Requirements for Plasma-Derived Products

    The European Medicines Agency (EMA) has released a draft Guideline on epidemiological data on blood transmissible infections intended to provide clarification on the data requirements for plasma-derived products. Background In the EU, companies must submit scientific data for blood- or plasma-derived medicinal products using the plasma master file (PMF) certification procedure. The requirement for PMF certification was established in Directive 2003/63/EC , which ...
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    EMA Adopts New Guideline on Urine-Derived Product Safety

    The European Medicines Agency (EMA) has adopted a new guideline on the regulatory requirements for ensuring the viral safety of urine-derived medicinal products. Background Human urine is an essential component in certain hormone-based treatments and some products used to break up blood clots. Products derived from human urine have been available in Europe since the 1970s. While numerous improvements have been made to ensure the safety and purity of these products, spe...
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    EMA Issues New Guideline on Gene Therapy

    The European Medicines Agency (EMA) is seeking feedback on a new draft guideline aimed at clarifying the scientific evidence necessary to support the authorization of new gene therapies. Background Gene therapy works by modifying a patient's genes to correct for genetic issues. Researchers have been studying gene therapy for the past 30 years, but few products have reached advanced stages of development. Because so few gene therapies have been submitted for authorizatio...
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    EMA in 2014: A Landmark Year for Approvals, With Eyes on the Future

    In the European Medicines Agency's (EMA) Annual Report 2014 , top regulatory officials describe the agency's role as both a "gatekeeper" and "enabler." This dual role means that the agency must not only work to ensure the safety of patients in the EU, but also to facilitate the development of new and innovative therapies. By the Numbers 2014 was a landmark year for EMA in many ways. The agency recommended record numbers of products to treat rare diseases , launched it...
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    EU Court Rules on Orphan Product Exclusivity

    A European Court has issued a ruling in an unlikely scenario dealing with overlapping periods of orphan product market exclusivity. In its ruling, which has the potential to influence how companies develop orphan products, the court found that authorized orphan products are entitled to market exclusivity, even when they are similar to an already approved product. Background Orphan product designation was first introduced in the EU in 2000 under Regulation (EC) No 141...
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    Rare Disease Patient Group Commends EMA, Wants EU-Wide Access to Treatment

    A rare disease advocacy network has applauded the European Medicines Agency’s (EMA) efforts to incentivize the development of treatments for rare diseases , but says  the variance in treatment access across the EU is “unacceptable.” In an interview with EurActiv , Terkel Andersen, president of the advocacy group EURODIS, said that EMA and the European Commission (EC) are “doing their utmost to try to make rare diseases ‘attractive’ for the pharmaceutical industry.” ...
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    EMA Issues Guidance on Clarification Meetings

    The European Medicines Agency (EMA) is looking to increase transparency between its committees and pharmaceutical companies under a new guideline that went into effect in February 2015. The guideline, EMA/636600/2014, details procedures regarding clarification meetings in response to questions raised by the agency during the review of a product using the centralized procedure. Clarifying Objections EMA believes increasing transparency between the agency and applicant...
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    Orphan Drugs in the EU: A Record-Breaking Year

    The European Medicines Agency (EMA) recommended 17 drugs with orphan product designation for approval in 2014, the most ever in a single year. This is much higher than the average of 6.75 per year between 2010 and 2013 and is a significant increase from 2013, when EMA recommended 11 products with orphan designation for approval. Background: Orphan Designation Orphan product designation was first introduced in the EU in 2000 under Regulation (EC) No 141/2000 . The reg...