• Regulatory NewsRegulatory News

    European Commission Wants to Know: Is EMA’s Fee System Fair?

    The European Commission on Thursday launched a public consultation as a part of a study evaluating the European Medicines Agency’s (EMA) fee system for approving and monitoring human and animal medicines. Until 2 August, industry and other stakeholders can offer their input on whether EMA’s current fee and remuneration system is “cost-based, fair, proportionate and not unduly complex.” Under this current system, EMA is funded by EU and European Economic Area (EEA) con...
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    Device Nomenclature: European Commission Explains What’s Coming

    The European Commission last month began explaining the details of how a future system for medical device nomenclature will help to support the EU’s new device and IVD regulations, as well as the Eudamed database, which allows for information to be exchanged between national competent authorities and the Commission. The nomenclature, which will be freely available to all stakeholders, will further align the EU with the International Medical Device Regulators Forum (IMDR...
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    FDA Reclassifies Needle Destruction Devices

    The US Food and Drug Administration (FDA) on Thursday finalized a proposal to reclassify needle destruction devices from Class III to Class II and to rename the device type to “sharps needle destruction” device. The final order will be effective 4 June 2018. The final order, first proposed in November 2017 , means manufacturers will no longer be required to submit a premarket approval application but can instead submit a less burdensome premarket notification (510(k)) ...
  • ReconRecon

    Recon: Sandoz Receives CRL in US for Rituximab Biosimilar as Another Trastuzumab Biosimilar Launches in EU

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Gottlieb previews drug price policy ( BioCentury -$) ( Stat ) ( Speech text ) Achaogen slides after ‘yes and no’ adcomm verdict on plazomicin ( Fierce ) ( MedPage Today ) Opioid Makers Sued for Premium Hikes in First-of-Kind Cases ( Bloomberg ) ( WSJ -$) Mylan Settles With Most Insurers In $67M Antitrust Appeal ( Law360 -$) Sandoz receives complete response lett...
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    EMA in 2017: An Agency in Flux

    The European Medicines Agency (EMA) spent most of 2017 trying to navigate how to deal with the UK’s move out of the EU, the agency’s own move to Amsterdam (with an eye toward being operational by 30 March 2019), and the subsequent loss of UK expertise, among other work described in a report on 2017 released Wednesday. Christa Wirthumer-Hoche, chair of EMA’s management board, explained some of the shifts that have occurred since the Brexit announcement, writing in the re...
  • FDA Updates Donor Screening Recommendations to Reduce Risk of Zika Virus Transmission

    The US Food and Drug Administration (FDA) on Wednesday released updated guidance for establishments that make donor eligibility determinations for those donating human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations for screening donors for infection with Zika virus. FDA notes that infections can be associated with a risk for developing neurologic complications, including Guillain-Barré syndrome. Deaths have been reported in associa...
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    Biocon Receives FDA Form 483 at Indian Biosimilar Manufacturing Site

    Biocon on Wednesday disclosed that its Bangalore, India-based sterile manufacturing facility received a Form 483 from the US Food and Drug Administration with seven observations. "The observations are largely procedural and aimed at continuous improvement. We will respond to the FDA with a corrective and preventive action plan in a timely manner,” Biocon said in a statement . “We have also this week received the preliminary report from the European Regulator post inspe...
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    Fresenius Alleges Akorn Knowingly Submitted Fraudulent Testing Data to FDA

    Details on why Fresenius last month sought to terminate its acquisition of Akorn, Inc. emerged on Wednesday, with Fresenius alleging a top executive at Akorn had knowingly submitted fabricated data to the US Food and Drug Administration (FDA). Fresenius alleged, according to Reuters, that an Akorn executive vice president for quality assurance in 2012 knowingly directed the submission of fraudulent testing data to FDA as part of an application to market the antibiotic a...
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    FDA Finalizes Guidance on User Fee Changes Under PDUFA VI

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance without any substantive changes from the draft on the new fee structure under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), and the types of fees for which industry is responsible. FDA said it reviewed the comments submitted to the docket on the draft from last October “and determined that they did not raise any relevant issues.” PDUFA VI created a structure whereby human drug...
  • Recon: FDA Approves Novartis’ Kymriah for Second Type of Blood Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US U.S. approves Novartis cell therapy for lymphoma ( Reuters ) ( Press ) ( Market Watch ) ( Fierce ) Kymriah’s label throws lymphoma potential into doubt ( EP Vantage ) A dying scientist and his rogue vaccine trial ( Wired ) Janssen to Acquire BeneVir Biopharm to Advance Immunotherapy Regimens for $140m Upfront ( Press ) ( Mass Device ) ( Endpoints ) ( Fierce ) Wh...
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    Industry Seeks Clarity on ICH Guideline on Estimands and Sensitivity Analysis in Clinical Trials

    The International Council on Harmonisation (ICH) needs to further clarify its addendum on estimands and sensitivity analysis in clinical trials, according to comments released this week from Pfizer, Teva, Alexion and Boehringer Ingelheim. According to ICH, the addendum, known as ICH E9(R1) , presents a structured framework to link trial objectives to a suitable trial design and tools for estimation and hypothesis testing. The framework introduces the concept of an esti...
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    Recon: Regeneron and Express Scripts Reach Deal on Cholesterol Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Regeneron And Express Scripts Reach A Deal On Embattled Cholesterol Drug ( Forbes ) ( CNBC ) ( Endpoints ) ( Press ) Bristol-Myers dumps late-stage IDO studies in wake of Incyte’s pivotal implosion in yet another setback ( Endpoints ) ( Fierce ) ( In the Pipeline ) It’s ‘going to be tough’: UC Berkeley struggles to find sympathetic court in CRISPR patent appeal ( ...