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    Medical Device Premarket Cybersecurity: TGA Finalizes Guidance

    The premarket requirements on medical device cybersecurity from Australia’s Therapeutic Goods Administration (TGA) came into effect on Thursday, with new details that further underscore the agency’s push for the total product lifecycle (TPLC) approach and international harmonization.   A 53-page final guidance sets the premarket cybersecurity requirements on manufacturers and sponsors of medical devices and in vitro diagnostic devices. Requirements are centered on es...
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    FDA Discusses RWD, RWE With Industry, Academia

    Industry, academia and US Food and Drug Administration (FDA) officials gathered Friday in Bethesda, MD to discuss the use of real-world data (RWD) and real-world evidence (RWE) in the premarket and postmarket settings. Jacqueline Corrigan-Curay, director of CDER’s Office of Medical Policy, kicked off the joint FDA-American Association for Cancer Research meeting to discuss FDA’s framework for using RWE, which was unveiled in December 2018 . The framework is meant to gu...
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    EU Ombudsman Concludes Inquiry on EMA Interactions With Medicine Developers

    The EU ombudsman this week said that it believes that the European Medicines Agency (EMA) should not allow the same experts to provide scientific advice to medicine developers prior to an application and evaluate the same medicine, claiming such overlap runs the risk of damaging impartiality or creating the perception of bias. In response to the comments, following a two-year inquiry into EMA’s interactions with drug developers, EMA said Friday: “Early interactions with...
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    FDA Validates Streamlined Review of SaMD Under PreCert Pilot

    In a Thursday update on the US Food and Drug Administration’s (FDA) Precertification (PreCert) pilot program for software as a medical device (SaMD), the Center for Devices and Radiological Health (CDRH) said retrospective testing supported the streamlined review of SaMD.   CDRH’s PreCert team retrospectively tested previously reviewed submissions in May to see if the accelerated review pathway tailored to SaMD products provides the same level of reasonable assurance o...
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    FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

    The US Food and Drug Administration (FDA) on Thursday published a technical specifications document to help sponsors submit next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drugs. The guidance explains how next generation sequencing (NGS) “adds complexity to the resistance analysis process,” which can make it challenging for reviewers “to analyze and validate the sequence information p...
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    FDA to Study Physicians’ Interpretations of Drug Information

    The US Food and Drug Administration (FDA) on Thursday said its Office of Prescription Drug Promotion (OPDP) will conduct a study to determine how factors such as information source, graphical presentations and time can influence physicians’ interpretation of information about prescription drugs presented in scientific journals versus promotional materials.   The study will also look at how the level of methodological rigor of the underlying data impacts physicians’ int...
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    Patient Registries May Prove Valuable in Regulatory Decisions, EMA Study Finds

    Although patient registries can be heterogenous in their quality and design, a new study in Drug Safety co-authored by a European Medicines Agency (EMA) official explains how patient registries could provide valuable data for regulatory decisions. The authors explain how such registries can be used when randomized controlled trials are not feasible, such as with some rare diseases, or to meet postmarketing commitments. “For products granted conditional marketing ap...
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    Office of Generic Drugs Explains Research Conducted in First Year of GDUFA II

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Thursday released a report on the two dozen research grants awarded related to complex generics in 2018, as well as the research done in seven other areas, including data analytics and combination products.  Thanks to the second iteration of the Generic Drug User Fee Amendment (GDUFA II), OGD was able to turn its research and scientific activities into 136 new product-specific guidances (PSGs...
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    EU Regulatory Roundup: UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation   Committees of British politicians have pushed back against the government’s attempts to adopt new drug and medical device legislation without holding debates in Parliament.   Last month, the UK government proposed changes to legislation intended to ensure the rules covering dru...
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    FDA, EMA Advise on Risk-Based Monitoring in Clinical Trials

    US and EU officials explained on Wednesday what their respective regulatory agencies look for in clinical trial risk-based monitoring (RBM) and how RBM can impact review times.   Under a cooperative agreement with the US Food and Drug Administration (FDA), the Duke-Margolis Health Policy Center convened the public workshop in Washington, DC for a debate on improving the implementation of RBM in clinical trials by identifying how regulators can help with some of the cur...
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    Amarin Plans Citizen Petition to Block Synthetic EPA in Supplements

    Amarin, maker of the fish oil-based triglyceride lowering drug Vascepa (icosapent ethyl), says it plans to file a citizen petition “within weeks” in an attempt to block companies from marketing products containing similar synthesized ingredients as dietary supplements.   Icosapent ethyl, the active ingredient in Vascepa, is a highly purified form of eicosapentaenoic acid (EPA) that was first approved by the US Food and Drug Administration (FDA) in 2012 to lower trigl...
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    FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance to help sponsors establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.   GnRH agonists and antagonists are a mainstay for treating patients with prostate cancer, FDA says, noting that it is one of the most common forms of cancer in American men.   “New drug applications for GnRH analogues typically rely, in part, ...