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  • Regulatory NewsRegulatory News

    CDRH warns 5 device firms in US, China, Hungary, Thailand and Taiwan

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released five warning letters sent to medical device manufacturers around the globe due to various violations. The release comes as device warning letters plunged nearly 90% over five years and as CDRH only issued nine warning letters in all of 2019. US For Nevada-based Steiner Biotechnology, an investigator from FDA’s Office of Bioresearch Monitoring Operation...
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    Clinical trials during COVID-19: Updates from FDA, MHRA and TGA

    The US Food and Drug Administration (FDA) last week updated its guidance from earlier this month on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.   The update comes as other regulatory authorities offer updates on managing new or ongoing clinical trials during the outbreak and as pharma companies have begun to halt or alter ongoing trials. Both European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulator...
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    Eudamed to Launch in 2022 for Both Devices and IVDs

    The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. The two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Dev...
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    Safeguarding the US Pharmaceutical Supply: Woodcock Discusses Challenges, Shift Overseas

    As drug and active pharmaceutical ingredient (API) manufacturing moves overseas to cut costs, quality and reliability concerns have been raised and the House Energy & Commerce Committee’s Subcommittee on Health met Wednesday to discuss the supply chain with one of the US Food and Drug Administration’s top officials and other experts. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained how part of the problem is that FDA does not know the...
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    FDA Floats Idea of a Rating System for Drug Manufacturers

    The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages supports the idea of creating a new rating system to help drug purchasers, including consumers, better understand the quality management of drug manufacturing facilities. “This idea envisions that pharmaceutical companies could, at their discretion, disclose the rating of the facilities where their drugs are manufactured,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, w...
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    Submitting Manufacturing Facility Information: Final FDA Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized a question and answer guidance on the type of manufacturing facility information that should be included in applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. FDA explains that the guidance is meant to help companies understand how not to submit extraneous information or misplaced or missing information that could result in delays, Refu...
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    PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use. PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, whi...
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    FDA Warns of Widespread Device Cyber Vulnerabilities

    Following other regulators’ warnings, the US Food and Drug Administration (FDA) on Tuesday alerted medical device manufacturers and other stakeholders to 11 vulnerabilities that may allow for remote control of a range of medical devices and changes to their functions that may prevent a device from functioning properly. The Cybersecurity and Infrastructure Security Agency within the US Department of Homeland Security also released an  advisory  in July about the cybersec...
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    FDA to Further Investigate Implantable Devices Containing Certain Metals

    Following concerns and reported adverse events linking biological responses to certain types of materials in medical devices, the US Food and Drug Administration (FDA) said recently that it will further engage stakeholders to investigate metal-containing implants and dental amalgam. Part of that engagement will involve a public advisory committee meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee on 13-14 November, which will discuss the...
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    Patient Engagement in Device Trials: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Monday released new draft guidance explaining how sponsors can improve the design and conduct of medical device clinical investigations by using patient experience, perspectives and other relevant information. The 10-page draft mainly addresses four questions: What approaches might sponsors use to engage patient advisors (defined by FDA as those who have dealt with or are dealing with a particular condition but are not inv...
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    First MDR Certificate Issued for Class III Device

    Notified body TÜV SÜD announced Thursday that it has issued the first Medical Devices Regulation (MDR) certificate for one of Germany-based Biotronik’s Class III (highest-risk category) medical devices, in addition to its quality management system. The newly certified device is Biotronik’s Renamic programmer software , which enables physicians to program and test implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators and cardiac resynchro...
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    Power Failures Land India-Based Cancer API Manufacturer a Form 483

    Following a five-day inspection last month, the US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Shilpa Medicare Limited after the agency uncovered long-lasting power failures at the site. “During the walkthrough on 24 July 2019, three power failures occurred within the facility during a 15-minute interval and a back-up generator did not resume power,” FDA investigator Yvins Dezan wrote. And while reviewing aud...