The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • 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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Patient Registries: EMA Wants to Make Better Use of Medicines Data

    The European Medicines Agency (EMA) on Friday is hosting a workshop to discuss ways to better use existing patient registries that collect high-quality data on drugs in clinical practice. Patient registries collect information over time on patients with a particular disease or who receive particular treatment during both pre-authorization and post-authorization periods. Such data can complement data from other sources to more effectively monitor drug risks and benefits. ...
  • Regulatory NewsRegulatory News

    FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions. The 21-page draft document, which is open for comment for the next 90 days, also explains how the agency plans to evaluate real-world data to determine whether it may be sufficiently relevant a...
  • Regulatory NewsRegulatory News

    CDISC Unveils New Standard for Clinical Trial Registries

    • 09 May 2016
    • By
    The new standard from the Clinical Data Interchange Standards Consortium (CDISC) will help industry generate submissions for multiple, global clinical trial registries, particularly those from the World Health Organization (WHO), European Medicines Agency (EMA) and from a single file. The standard, known as the Clinical Trial Registry (CTR) XML, is inspired by the International Committee of Medical Journal Editors (ICMJE), and is based upon the 2...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    Leprosy––Not Yet Consigned to History

    The word leprosy brings to mind a gruesome disease that separates its sufferers from society and continues to strike fear into communities, much like Ebola. While the genome for leprosy has been sequenced and there is a drug cocktail that effectively cures the disease, its mode of transmission still is unknown. A disease that dates back through millennia, leprosy so far has eluded efforts to find the final piece of information that might eradicate it from the world per...
  • Overestimated Efficacy, Underestimated Risks Guide Patient Treatment Options

    • 13 November 2012
    • By
    Patients and physicians alike often have lofty expectations and aspirations about the effectiveness of a prospective treatment. But, as a new article in the Annals of Family Medicine argues, those expectations contribute significantly to both the increasing costs of healthcare and avoidable harms suffered by patients. At the core of the healthcare cost crisis right now is an unavoidable fact, writes Steven Woolf, MD: The cost of obtaining healthcare, and in particular ...