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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...
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    New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada, Canada’s medical device market regulator, has published new  guidance  requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications. Set to take effect 1 December 2014, the new rules will require Class III and IV MDL applicants to submit premarket review documentation...
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    FDA Releases New Electronic Submission Requirements for Biological Products

    A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) outlines a new process of submitting lot distribution reports (LDRs) in electronic format. Background As required by 21 CFR 600.81 , LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted at least every six months, though FD...
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    IMDRF Moves Forward With Effort to Standardize Global Device Submissions

    The International Medical Device Regulators Forum (IMDRF) has released two final documents that, once implemented, should make it much easier to get medical device products approved in multiple regions, including the US, EU and Canada. Background IMDRF launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), which disbanded in December 2012 after its device regulatory members decided to split off and form their own juncture withou...
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    Legislators Call for FDA to Further Restrict Use of Phthalates in Medicines, Citing Risks

    In December 2012, the US Food and Drug Administration's (FDA) drug regulatory body, the Center for Drug Evaluation and Research (CDER), indicated that it wanted to limit the use of some phthalates as excipients in medicines. Now two legislators have a message for the agency: There's more that needs to be done. Background FDA's December 2012 guidance, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products , explained that the agency had foun...
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    FDA Adds Three New Pathogens to GAIN Act Qualifying List, But Impact Remains Unclear

    The US Food and Drug Administration (FDA) has released an updated and final list of pathogens that are eligible for special incentives under the 2012 Generating Antibiotics Incentives Now (GAIN) provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) . Background The GAIN Act was passed in an attempt to incentivize the development of new antibiotics—a response to both growing rates of microbial resistance to antibiotics and a dearth of...
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    FDA Finalizes Expedited Product Guidance With Hundreds of Major, Minor Changes

    The US Food and Drug Administration (FDA) has finalized its long sought-after guidance document on the use of its four expedited drug approval programs, including the recently instituted breakthrough product designation. Background FDA released the draft expedited programs guidance, Expedited Programs for Serious Conditions—Drugs and Biologics , in June 2013. In the draft, FDA outlined how it says it planned to use four tools at its disposal designed to expedite ...
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    FDA, Absent From Hearing, Makes the Case That it's Increasingly Innovative

    Yesterday, US legislators in the House Energy and Commerce Committee held a hearing to discuss how the federal environment—including the US Food and Drug Administration's (FDA) regulations—might be improved to bolster drug innovation. But while the pharmaceutical industry, device industry and patient groups found themselves well represented at the meeting, one prominent stakeholder found itself conspicuously excluded from the meeting: The US Food and Drug Administration. ...
  • EMA Revamping How it Handles Submission of Applications and Requests for Advice

    The European Medicines Agency (EMA) has announced that it will soon change the way it handles changes to approved marketing authorizations (MAs) and other regular reports. Background As in the US, pharmaceutical companies are required to notify EMA of all changes made to their medications and manufacturing processes, as well as keep regulators informed about the safety of their products and any transfers of ownership. Those changes fall into several categories , inclu...