• Feature ArticlesFeature Articles

    Considerations for selecting control groups in pediatric clinical trials

    ICH E10 provides specific guidance on the choice of control groups for clinical trials, but there are additional considerations for choosing a control group for a pediatric trial. In this article, the author looks at different types of control groups and the specific challenges that present when considering the design for a pediatric trial, such as the medical condition being treated, the potential patient population, suitability of comparators, and availability of real-wo...
  • Regulatory NewsRegulatory News

    FDA updates safety communication for robotically assisted surgical devices used in mastectomy

    The safety and effectiveness of robotically assisted surgical devices has yet to be established in the prevention and treatment of breast cancer, according to an updated safety communication released by the US Food and Drug Administration (FDA).   The agency reiterated that use of these devices has been cleared for procedures such as hysterectomy, prostatectomy, and colectomy based on data from 30-day patient follow-up. However, robotically assisted surgical (RAS) devi...
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    FDA Finalizes Buprenorphine Drug Development Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing new types of buprenorphine depot products for medication assisted treatment (MAT) for opioid use disorder amid the ongoing opioid epidemic.   Buprenorphine, along with methodone and naltrexone, are the only drugs approved by FDA to treat opioid use disorder.   Buprenorphine MAT works by reducing patients’ withdrawal symptoms and blocking the euphoric effects of other opioid drug...
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    Opioids: GAO Calls on HHS to Assess Effectiveness of Expanding Medication-Assisted Treatment

    The Government Accountability Office on Tuesday issued a report calling on the US Department of Health and Human Services (HHS) to assess the effectiveness of efforts to expand the use of medication-assisted treatment (MAT) for opioid addiction. The report follows a House hearing last week in which FDA Commissioner Scott Gottlieb announced several steps the agency will take to promote the development and use of MAT. Background The report and Gottlieb's testim...
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    Gottlieb: Next Steps in Opioid Crisis May be 'Uncomfortable'

    In testimony before the House Energy & Commerce Committee on Wednesday, FDA Commissioner Scott Gottlieb said that the next steps in efforts to combat the ongoing opioid crisis will be difficult, but necessary given the spread of the epidemic. "We'll need to touch clinical practice in ways that may make some parties uncomfortable," Gottlieb said, pointing to restrictions on prescribing and mandatory education for physicians as possible steps. "Long ago we ran out of stra...
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    FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information

    Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion. The new administration’s impact on FDA was not discussed, though some officials discussed how FDA is moving forward with initiatives begun under President Barack Obama’s administration. Elizabe...
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    FDA Warns of Risks From Fluid-Filled Stomach Balloons to Treat Obesity

    The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers noting the receipt of dozens of reports for two different types of adverse events linked to fluid-filled intragastric balloons used to treat obesity.  “The first type of adverse event involves the fluid-filled intragastric balloon over-inflating with air or with more fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need for premature device removal...
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    ICH Working Group to Provide More Detailed Guidance

    The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues. According to a new concept paper endorsed by the ICH MedDRA (Medical Dictionary for Regulatory Activities) Management Board in November 2016, topics that ...
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    Confusion Pushes FDA to Change Antidepressant’s Brand Name

    The US Food and Drug Administration (FDA) on Monday approved a brand name change for Takeda’s antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from confusion with AstraZeneca’s blood-thinning medicine Brilinta (ticagrelor). The new brand name of Brintellix will be Trintellix, and the tablets will look nearly identical and are expected to be available in June, FDA said. “No other changes will be made to the la...
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    Final FDA Guidance on Drug Design Seeks to Reduce Medication Errors

    The US Food and Drug Administration has finalized guidance detailing best practices on how to improve a drug's container closure system to minimize the risk of medication errors. Medical errors, which include medication errors, are one of the leading causes of preventable death in the US. A report published by the Institute of Medicine (IOM) in 1999 found that between 44,000 and 98,000 Americans die each year due to medical errors, though other estimates place that figur...
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    EMA Offers New Draft Guidance on Developing Alzheimer’s Treatments

    The European Medicines Agency (EMA) on Monday released new draft guidance on the development of Alzheimer’s disease treatments that would allow treatments to be evaluated in earlier disease stages before dementia sets in. The new guidance comes as EMA recognizes that the field of Alzheimer’s disease (AD) research and development “witnessed a recent paradigm shift in the diagnostic framework of AD which is now considered a continuum with a long-lasting presymptomatic phas...
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    EMA Sets Up Two-Year Pilot Program on Patient Registries

    The European Medicines Agency (EMA) has launched an initiative focused on existing patient registries, with the aim of seeing how they can be better used as a source of post-authorization data, and how they can help to establish new registries. Background EMA defines a registry as a system using observational methods over time to collect uniform data on a population defined by a particular disease, condition, or exposure. A disease registry includes patients bas...