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    Australia Hits Pause on Implementing Regulatory Changes for Device 3D-Printing

    Australia’s Therapeutic Goods Administration (TGA) is delaying implementation of regulatory changes proposed for the additive manufacturing, or 3D-printing, of devices, following requests from stakeholders to provide clarifications.   “The TGA plans to further explore other areas that were identified as requiring additional clarity prior to implementing regulatory change,” the regulatory authority said in a Thursday notice.   TGA received 24 comments on the regulat...
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    Australia Spells Out Regulatory Requirements on Lab-Developed IVDs

    Australia’s Therapeutic Goods Administration (TGA) unveiled guidance Thursday explaining how a laboratory can meet in vitro diagnostic (IVD) regulatory requirements.   The regulatory framework applies to IVDs manufactured and/or modified in-house, though those that are supplied outside of a laboratory or laboratory network, as well as those developed solely for research purposes, fall outside of the requirements’ scope, TGA clarified.   Australian laboratories’ t...
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    Senate Committee Advances Bill Boosting FDA’s FY2019 Budget by $159M

    The Senate Appropriations Committee on Thursday signed off on a $159 million increase in discretionary funding for the US Food and Drug Administration (FDA), though that increase was about $150 million less than the increase proposed in the House.   According to the Alliance for a Stronger FDA, the additional funds requested by FDA are planned to promote domestic manufacturing (House committee bill has about $27 million more in it for this), expand FDA engagement with ...
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    FDA Issues Guidance on Maximal Usage Trials for OTC Drugs

    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance for drugmakers on the design and conduct of maximal usage trials for the purpose of adding a topical active ingredient to an over-the-counter (OTC) drug monograph.   Maximal usage trials are conducted to determine the in vivo bioavailability of topical drugs and can help the agency understand the potential for systemic exposure to a topically applied active ingredient.   “Such information ...
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    EU Regulatory Roundup: ENVI Proposes Changes to HTA Cooperation Regulations

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   ENVI Proposes Changes to Regulation on Health Technology Assessment Cooperation   The Committee on the Environment, Public Health and Food Safety (ENVI) has submitted proposed changes to the European Commission’s planned regulation on cooperation between health technology assessment (HTA) bodies.   Members of the Commission are seeking to implement the regulation ...
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    Kickback Allegation Settlements Pile Up for Pharmaceutical Companies

    Fresh off the Novartis scandal, in which the company paid President Donal Trump's lawyer, the Department of Justice (DOJ) on Thursday announced that Pfizer agreed to pay $23.85 million to resolve claims that it used a foundation as a conduit to help pay the copays of Medicare patients using three of its drugs. But Pfizer is just one of many pharmaceutical companies paying tens or even hundreds of millions to settle these allegations. In explaining why a company would he...
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    FDA Finalizes Guidance on Developing Anthrax Treatments

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing drugs to protect against inhalation anthrax.   The guidance finalizes a draft released in 2016 and has been updated to revise the indication of prophylaxis of inhalation anthrax to cover both the pre- and post-exposure settings.   The indication now reads "to reduce the risk of disease in persons who have inhaled, or are likely to imminently inhale, aerosolized B. anthracis sp...
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    UK Prepping for Different Brexit Scenarios

    Sounding a note of optimism, the UK government released a report Wednesday calling again for the nation to remain a part of the European Medicines Agency (EMA) in some form, adding that “the prospect of a ‘no deal’ scenario is highly unlikely and therefore we are in a strong position from which to seek to agree a mutually beneficial way forward.” “The safety of patients is of paramount importance to the Government’s exit negotiations for medicines, medical devices and s...
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    Health Canada to Transition to Global Medical Device Nomenclature

    Health Canada announced Tuesday that it is initiating a transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), as part of a push to improve the availability, access to and quality of information available on medical devices in Canada. Later this month, Health Canada says it will provide manufacturers with a list of their medical devices associated with active medical device licenses. “Manufacturers will be i...
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    EMA Begins Public Consultation on Draft Guideline for Handling and Shipping Investigational Medicines

    The European Medicines Agency (EMA) on Wednesday opened for consultation a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs). The guideline says investigational medicines should remain under the control of the sponsor until after completion of a two-step procedure, which consists of the batch certification by the Qual...
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    EMA Report Makes Recommendations for CAR-T Patient Registries

    A new report from the European Medicines Agency (EMA) lays out recommendations for improving the use of patient registries to support the benefit-risk evaluation of chimeric antigen receptor (CAR) T-cell therapies.   The report comes as EMA considers whether to approve the first batch of CAR T-cell products submitted to it for marketing authorisation, including applications for Kite’s Yescarta (axicabtagene ciloleucel) and Novartis’ Kymriah (tisagenlecleucel) , both...
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    Asia Regulatory Roundup: TGA Tweaks Plan to Increase GMP Fees

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Tweaks Plan to Increase GMP Fees and Charges After Industry Rejects Proposals   The pharmaceutical industry has pushed back against plans to increase the fees and charges associated with good manufacturing practice (GMP) regulatory processes in Australia. The country’s Therapeutic Goods Association (TGA) tweaked and delayed its proposals in response, but is push...