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    Industry Groups Question Aspects of CDRH’s AI/ML-Based SaMD Framework

    Feedback on the US Food and Drug Administration’s (FDA) proposed regulatory framework for artificial intelligence- (AI) and machine learning- (ML) based software as a medical device (SaMD) underscores the uncertain environment for developing such products. The comment period on a discussion paper that proposed the framework in April closed last week with more than 100 comments, most of which were made public on Friday. Many commenters tout the efforts of the FDA’s Cen...
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    Health Canada Notice Details When Off-Label Use is not Considered Investigational in a Clinical Trial

    Health Canada last week issued a notice clarifying the circumstances in which the off-label use of an authorized drug in a clinical trial would not be considered investigational.   The agency says the notice, which went into effect on 5 June, will “serve as interim interpretive guidance until amendments can be made to the Food and Drug Regulations.”   Health Canada says its previous interpretation of the regulations governing clinical trials led it to require drugs...
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    FDA Moves Compounding Program to Office of Compliance

    In an email to staff distributed Monday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said the agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.   In the aftermath of the 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths, FDA created an agency lead for compounding within C...
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    FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

    The US Food and Drug Administration (FDA) said Friday it will host a 2-day public workshop on leveraging randomized clinical trials to generate real-world evidence (RWE) for regulatory decisions. The Duke-Margolis Health Policy Center will convene the workshop under a cooperative agreement with FDA to explore how randomized clinical trial designs, including those that incorporate pragmatic design elements, can use real-world data (RWD) to generate RWE in clinical settin...
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    EU MDR: COCIR Offers Recommendations on Notified Bodies, Grace Period

    The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued new recommendations on the availability and capacity of notified bodies (NBs) and the sustainability of the grace period under the European Union’s (EU) medical device regulation (MDR). The recommendations, detailed in a position paper released Thursday, address challenges with the ongoing lack of NBs designated under MDR and confusion regarding the regulati...
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    CDER Drafts Drug Development Guidance on NASH With Compensated Cirrhosis

    The Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) issued draft recommendations for sponsors looking to develop drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. NASH is associated with a range of common diseases, including type 2 diabetes, hypertension and obesity, among others. “It is a growing public health concern and is anticipated to be the leading cause of liver transplantation within a dec...
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    FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.   “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibi...
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    EU MDR/IVDR Coordination Group Answers Questions About Notified Bodies

    The European Commission (EC) issued a Q&A document on Thursday to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs). The 8-page document endorsed by the Medical Device Coordination Group (MDCG) answers four sets of questions on a range of MDR/IVDR requirements relating to NBs. The clarifications cover organizational and general requirements, as well as resources requirements and process requ...
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    EU Regulatory Roundup: MHRA Advises Against Use of Paclitaxel Devices Amid Mortality Fears

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news. MHRA Advises Against Use of Paclitaxel Devices Amid Mortality Fears   The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has said not to use devices featuring paclitaxel in the routine treatment of patients with intermittent claudication. MHRA took the action after finding the potential mortality risk outweighs the benefits in this pat...
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    Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products

    Branded and generic drugs industry groups are sparring over the US Food and Drug Administration’s (FDA) approach to regulating biosimilar and interchangeable insulin products following a public meeting on the matter last month.   In March 2020, FDA will begin transitioning certain biological products – such as insulin, insulin analogs and human growth hormone – that were initially approved under new drug applications (NDAs) to be deemed to be licensed under section 3...
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    NESTcc Taps Apple Watch as First Wearable Project

    The National Evaluation System for health Technology Coordinating Center’s (NESTcc) 12 new real-world evidence (RWE) test cases marked its first active surveillance project—the US Food and Drug Administration’s (FDA) test case on synthetic mesh slings—and the first test case to involve a wearable, with the Apple Watch. New in NESTcc’s portfolio is also the first research question submitted by a patient advocacy organization. Projects that will include patient-generated ...
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    Mallinckrodt to Settle With DOJ for $15m as Another Complaint is Filed

    Drugmaker Mallinckrodt said Wednesday that it will likely pay $15.4 million to settle charges made by the Department of Justice (DOJ) related to sales and marketing activities of a company acquired by Mallinckrodt. But the DOJ also filed another complaint Wednesday under the False Claims Act , claiming that Mallinckrodt used a foundation to pay illegal kickbacks in the form of copay subsidies for its expensive drug known as H.P. Acthar gel, which is used to treat multi...