• Regulatory NewsRegulatory News

    IMDRF Consults on Use of Registries to Support Device Approval Decisions

    The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making. Background Registries, which can capture outcomes associated with medical device use, were identified by IMDRF in 2014 as having "a significant gap" in optimal use for regulatory decision making. This gap led to the creation of IMDRF Registry Working Group ...
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    Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds

    The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found a higher association with these expedited pathways and the likelihood of safety-related labeling changes than with non-expedited pathways. In their analysis of 15 years of data, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Program on Regulation, Therapeutics, And Law...
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    FDA Approves 6th Biosimilar in US, Second for Humira

    The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab). Cyltezo, which follows the approval of Amgen's Amjevita (adalimumab-atto) last September , has been approved for multiple indications (see link to label below), did not go before an FDA advisory committee and was not approved as an interchangeable biosimilar. How...
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    Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market

    Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks and clinical trial designs of new drugs and medical devices sped to market without enough preliminary evidence that they are effective. In one of the articles, which evaluated the use of FDA’s accelerated approval pathway, questions were raised on the use of surrogate measures as outc...
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    New Research Compares Drug Regulators Around the Globe

    Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals. Of the regulators in the more established major pharmaceutical markets (the authors from the European Center of Pharmaceutical Medicine and Novo Nordisk point to the US, Europe and Japan as being the regulators in such mark...
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    Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate

    A recent study in Health Affairs suggests that drugs given an expedited review by the US Food and Drug Administration (FDA) offer greater health gains than drugs that receiving a conventional review. But experts caution that the study might only show incremental benefits. The study, conducted by Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health and three of his colleagues at Tufts Medical Center, compared the change in quality-adjuste...
  • Feature ArticlesFeature Articles

    Conditional Approvals for Early Access to New Medications

    This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US. Introduction Before a medicinal product for human use is authorized to enter the market, it must undergo extensive study to ensure its s...
  • Feature ArticlesFeature Articles

    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
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    FDA Approves 5th Biosimilar, 2nd for Remicade

    The US Food and Drug Administration (FDA) on Friday announced its fifth biosimilar approval: Samsung Bioepis’ Renflexis (infliximab-abda), an intravenous infusion for multiple indications. This is the second FDA approval for a biosimilar to Johnson & Johnson’s Remicade (the first was Pfizer and Celltrion’s Inflectra (infliximab-dyyb)), though both Inflectra and Renflexis have been approved as biosimilars but not as interchangeable biosimilars. The shift in the...
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    505(b)(2) Approval Pathway: Not Necessarily Shorter Approval Times

    With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development. Background Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosme...
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    FDA Officials Defend Agency's Flexibility Under Current Regulatory Framework

    Top officials at the US Food and Drug Administration (FDA) are defending the agency's flexibility to accelerate the availability of products by considering diverse data sources in product submissions. In an article in Nature Reviews Drug Discovery on Friday, Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, writing alongside former FDA Commissioner Robert Califf and other high-ranking agency officials, argue ...
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    FDA’s Approval of a New Abuse-Deterrent Opioid Raises Questions

    The US Food and Drug Administration (FDA) on Monday raised some eyebrows with its approval of another long-acting opioid, Egalet’s Arymo ER (morphine sulfate extended-release tablets), with abuse-deterrent properties. What makes this approval unique is not only the oddly-worded FDA explanation of an another opioid's marketing exclusivity in relation to this approval, but the agency overriding a nearly unanimous advisory panel of outside medical experts. Back in August,...